Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastases)

[marvass]

I have been searching this site amongst many others, for clinics that do Intrathecal Herceptin for Leptomeningeal Metastases in HER2+ Breast Cancer.

Till now I got information that there are two trials going on and recruiting at the moment.

http://clinicaltrials.gov/ct2/show/NCT01325207?term=Intrathecal+Trastuzumab&rank=1

http://clinicaltrials.gov/ct2/show?term=Intrathecal+Trastuzumab&rank=2

Also found out that two persons have been treated in LA and TX.

Are there any more doing it?


Mario

[Jackie07]

Hi Mario,

Welcome to Her2 support.

Below are two recent threads of previous discussions on the subject. More can be found by using the 'Search' fuction on top of the Board.

http://her2support.org/vbulletin/showthread.php?p=269040&highlight=leptomeningeal+metastasis#post269040 (http://her2support.org/vbulletin/showthread.php?p=269040&highlight=leptomeningeal+metastasis#post269040)

http://her2support.org/vbulletin/showthread.php?t=50175&highlight=intrathecal (http://her2support.org/vbulletin/showthread.php?t=50175&highlight=intrathecal)

[marvass]

Hi Jackie,

Many thanks for your help.
I had not seen greg's information on this but seen Lani's.
Have just learnt that doctors are doing this IT Herceptin at MD Anderson, Cedar Sinai and UCLA, not as trials.

Still looking for someone closer to us, NY.

Thanks again
Mario

[marvass]

From what I learned in the last days that IT herceptin is working fine with most of who tried it. It kills brain mets HER2+ Breast Cancer, and its only a matter of a few months before this would be the first option for all that herceptin worked on them intravenous, and then spread only to their brain, because of the BBB. There are a few doing it right now besides the two trials, but still no one around NY !! Can't believe it, I'm sure there are... Let's hope I find out someone.

[marvass]

Got to know that in small dose, less than 50 mg it does not work.
At chicago trial the dose is low while in off protocol they are giving 100 mg or so and it is curing most of those trying it.
There are three papers talking about IT herceptin and they both conclude that it was successful. Simply cannot understand why not much are doing it.

[Rolepaul]

Mario,

This is very frustrating for me as well! Did Carol end up getting treated in France? I am going to MD Anderson on 5/16 and can see if Carol would be able to get treated there.
Paul

[marvass]

Hi Paul,
Still working to get somewhere, chicago still doing 10mg per week and then 10 mg every two weeks, think it does not do much.
France and MD Anderson still chasing, nothing at hand yet.
If you meet your doctor ask her if she is taking more for she gave us no reply in 10 days !! Even though the secretary promised a reply, because she was away all the time.

Regards
Mario

[Rolepaul]

Mario,

I sent some contacts at Genentech and NCI to you. I will follow up with MD Anderson people on Thursdya or Friday of this week.

Paul

[marvass]

After all we got accepted both in france and chicago trial, but never went, because our oncologist decided that he will do it for us, because he believed that this was the best available.


My wife started 18 days ago on IT herceptin. Already took 30mg first week, then 30mg second week, and 50mg two days ago. No side effects except for a headache peaking two days after administration, which can be controlled through pain killers and light dose of steroids.


It looks like it is working because she already feels much much better. Well, we believe strongly that this is the best available treatment for breast cancer mets in the brain when you are HER2+.



Will keep you updated with next MRI in less than a month.


Mario

[marvass]

Here's an update:

Till now my wife took 30, 30, 50, 50 and 60 mg intrathecal herceptin together with some steroid, one dose every week, escalating this way, and 6 mg per kilo intravenous herceptin, one dose every three weeks. Side effects are none, not even a headache anymore. MRI will be done next week, will post results here. Fingers crossed.


Mario

[JennyB]

Fingers crossed

[karen z]

thanks for your post.

[Rolepaul]

I am staying touch with Mario as Carol, his wife, has a treatment method that is so monumental in how it is being done. This uses a method that should be able to be implemented very easily with existing methods and drugs. To be able to save potentially thousands of women a year with brain and/or spine HER+ involvement needs to be pushed by everyone who reads this forum.

[schoonder]

Would neo-adjuvant t-dm1 after surgery reduce possibility of brain mets if treatment was effective in eradicating remnants of disease that are currently undetectable?

Would intrathecal t-dm1 make for an effective tool in treating her2+ brain mets?

[Rolepaul]

No one to my knowledge has ever done TDM-1 via intrathecal administration means. If there is no brain or spine mets detected within seven years after mastectomy, there is a high level of faith that there will not be found later. The problem is that these is no absolute way to make sure that there is not any involvement in the brain and spine prior to that. If there is no lymph node involvement, that would indicate that there is also a low likelihood of brain or spine involvement. The difference between now and the past is that it is clear that the previous methatrexate and other "harsh" chemical treatments caused side effects that were unacceptable, with IT Herceptin now being tested by several individuals for side effects (and finding none).

[KDR]

How does this work exactly? What is the set-up? IV to the head or what?

Karen

[Rolepaul]

Intrathecal can be done through a lumbar puncture hole, but is more commonly done through an Ommaya reservoir. This is a small under the skin plastic bag (think mini IV bag) with a septum to add the medications and a tube that allows the solution to go through a hole drilled in the skull to the brain cavity. Past issues with irritation of the brain lining from the tube or medication are better understood and not as much a problem. The medications are then added through the skin with a needle the size of a vaccination, with little pain or risk of infection. The medication volume is offeset by first removing an equivalent amount of fluid from the reservoir, which than can be used to flush the solution in the line at the end of medication addition or sent to the lab for study of the CSF for blood cells, glucose (high is good), protein (low is good), or tumor markers (undetectable is great). This is on the side of the blood brain barrier that most testing cannot see. That is why it is such a great tool if brain or spine involvement occurs.

[marvass]

Thanks everyone for wishes and interest.
We are doing this through lumbar puncture, which is just an injection through the lower back with little pain and takes just a few minutes a week. Then just a little dose of steroids, 2mg pill per day and that's it. Within a few weeks. then the time period is extended, I know of one doing it every 6 weeks and another planning to go for once every 3 months. When all is clear then I think that it must be done for a year or two and then stop completely. But this is still experimental. But I don't think there is anything more effective. Lets see the outcome of the results in 2 days!!

[Joan M]

Good luck, Marvass. I'm going to ask my neuro-onc about the procedure. When I first had a brain met in Oct 2008 I asked my former neuro-onc (who was at the same institution as my current one, but has since left), and he had never heard of it. I was a little surprised because it was at Sloan-Kettering. I was prompted to ask him, because I had read about a trial in Germany about intrathecal herceptin. That was the only information I could find about the procedure at that time. I wonder what the new neuro-onc will say.

I was treated with Herceptin at Sloan-Kettering for only about a year or so, but switched to another hospital a little over a year ago. However, I've had other services there and continue to follow up with them.

Joan

[marvass]

Thanks Joan, I don't think sloan-kettering did it ever, but they might do it in collaboration with the trial in chicago, worth giving it a try.
Good luck to you too.
Mario

[marvass]

MRI results of today:
Thank God, no progression. Herceptin is working and there are no new tumors. And all present brain tumors are same size as two months ago, even with such a small dose of intrathecal herceptin. So on the way of getting destroyed, just as all the previous that did this. Next MRI in 6 weeks and we should find nothing left!!

[KDR]

Yay! Sending warm love your way!
Karen

[marvass]

Thanks Karen
God bless you.

[Rolepaul]

Mario,

As always, Nina and I are thinking of you and Carol. We are hoping for the same success as Nina had.

Paul

[KDR]

Joan,
When you find out, let us know. It'd be interesting to see if your facility is working with the Chicago facility. If they aren't could you ask why?
Thanks
Karen

[marvass]

We were told that we could start at Chicago and then be transferred to Sloan Kettering after a few weeks. You have to try.
Thanks everyone.
Mario

[KDR]

What facility are you at in Chicago?
Karen

[Rolepaul]

Chicago is Dr. Raizer at Northwestern. You can contact him through a google search. He is now at 30 mg twice per week in his study.

[marvass]

Dose escalated to 90 mg IT herceptin together with 25 mg IT hydrocortisone (steroid) per week, as from this week. Should do the trick. Took first dose and still no side effects with this higher dose. Fingers crossed. Have to bear with me for another 6 weeks for results.

[ehower]

Mario,

First of all, thank you for your posts. I hope your wife is continuing to do well. I, too, have brain mets-her2neu breast cancer. I am supposed to start Tykerb and Xeloda but Xeloda is a chemotherapy drug and OH- I just don't want to do any chemo again if I can help it. So, my question is, while your wife is taking intrathecal Herceptin, is she also on any chemotherapy, or is it just the IT Herceptin that is so effective. Your posts have been a buoy for me and have offered me hope. Thank you! I hope you are both doing well.

[Rolepaul]

Nina (my wife) had IT topotecan at the same time as IT Herceptin, but Carol (Mario's wife) only had straight IT Herceptin.

[marvass]

Hi ehower,
No chemo, just IT and IV herceptin. Looks like it is the IT herceptin that does the best work for brain mets. Wish you luck.
Mario

[ehower]

Mario and Paul, Thank you so much for getting back to me. Now, if I can find someone to administer it to me!!!!! That's my next search! Mario, How did you talk Carol's oncologist into doing it? Mine said no! I'm getting a 2nd opinion at the CTCA in Chicago but I'm in PA.

To both of you and your wives, I wish you the best. My thoughts are with all of you!!

Eileen

[marvass]

Our oncologist suggested it himself when we told him that we where getting the trial. So it wasn't a problem.
But chicago are still recruiting and giving 30mg twice a week. Good luck eileen and may you find a way quickly.
Mario

[marvass]

Quick update, last week dose escalated to 100 mg IT herceptin and 50 mg IT hydrocortisone per week (together with IV herceptin 6 mg per kilo every 3 weeks). Carol is feeling fine, no funny feelings anymore, just as if she is cured. She did not need any painkillers or oral steroids this week, just after 7 IT procedures. From outside everything is looking great, now have to wait another 4 weeks or maybe less (too eager to wait this long!!) for next MRI. Fingers crossed.

Will keep you posted.
Mario

[Rolepaul]

Nina had some pain in her lower back for the past few weeks. Although MRI scans were not scheduled until the first week in August, Early spine and brain scans were run on Friday and Monday. The result was that no evidence of disease was found in either area. Looking at blood cells under a microscope, there are no abnormal ones seen. Tumor markers are down to non-disease population levels. Spinal tap glucose and protein are also at non-disease population levels. PET scan is clear. Bone scan is clear. Nina actually gave massages on Monday (She is both a RN and a massage therapist) to relieve boredom and have some additional funds. Her treatment was in Houston (where she lived with her brother) and my work is in Raleigh North Carolina. Every two weeks I go to visit, and she travels to visit other family members as well. Her income will help with the expenses that are incurred. She went from being at the hospital as much as four days a week early in treatment to now looking at once every two weeks, with IT and IV treatments on the same day. It has been tough on us mentally, physically, and financially; but I can tell you her quality of life has been very good.

Carol and Nina took a chance on an inovative method of central nervous system treatment. The parts of the treatment were previously in place, however the borrowing of the pieces from other treatments was used to make a new treatment. I believe this should bring hope to those who have seen Her+ creep into the brain and/or spine. Both Mario and myself fought for our wives to get treatment that has made a difference in outcome. I hope this leads the way to other doctors accepting this as a way to retun patients to a normal life.

Mario and Carol are truly amazing. They came to the US to get treatment, as well as to France. The treatment that was done in Malta was the reason. After only 7 treatments to have the ability to be almost back to normal is exciting. This is so different from the vast majority of outcomes that there needs to be continued work beyond the Northwestern and France studies. I heard MD Anderson would like to run a multi-center clinical trial to get Intrathecal treatment for Herceptin positive patients with CNS involvement. If an Ommaya reservoir is placed, treatment literally takes less than fifteen minutes to complete. IV treatment for the whole body is another 30 to 60 minutes. Insurance coverage is a must, and we have had good luck with Anthem Blue Cross Blue Shield.

To all out there, do not give up hope. There are so many clinical trials, new drugs, new methods with older drugs, and people willing to share there stories. I inspire you to perspire. Go use the internet. You have a patient case load of one. If you need help with a consideration, ask your physician. If they do not want to take the time, move to another one. If you ask, they should investigate. If you ask for something, provide them with your reasons why. We gave seven cases histories for IT Herceptin that came from the internet. If you are unsure, get on a forum board like this one. Lani has one of the best points of contact with this subject matter in the world. Many of the ones on this site will tell you their results from a treatment pattern. You will also hear stories that tear your heart, as well as the success stories that give you hope. Carol and Nina should be the ones that let you know there are good outcomes even with the most dire predictions.

Never give up (Kevin Costner as Elliot Ness in the Untouchables)
I hate to lose (William Shatner as James T. Kirk in the Wrath of Khan)

Use this for inspiration.

[Rolepaul]

ehower,

Please have your physician contact Monica Loghin at MD Anderson in Houston Texas. She can give the doctor information about how it was administered for Nina, the clinical signs to look for, and the outcome that shows No Evidence of Disease in the brain, spine, or rest of the body. Then I would appeal to the next level within the administration. If that does not work, I would look at a major cancer center and ask them if they will try it (Clevela nd Clinic in the West, maybe Sloan Kettering in the East). The way to explain it is that Herceptin is the standard treatment for HER+ disease, intrathecal treatment is the standard for CNS involvement, and that the two together are the natural development (Reese's Peanut Butter cups concept). Both have been used for ten years, so there is adequate history on them separately. If you google search "Herceptin Brain" there is a case in Germany performed by a Spanish doctor which had exceptional results. Likewise, there was one in Japan, and a couple more that I was able to access. I only had four days to do research due to the deterioration in health that was occurring in Nina's case. Then do a "Compassionate Care" request. This is like a one person clinical trial. You will sign that you and your your family will not sue the doctors for any negative outcome. If they chose to you an Ommaya reservoir, there will be a short general anasthesia operation to place it. If you choose lumbar puncture, that surgical intervention is not needed. I would pick 40 mg for a couple of doses to determine if there is a negative reaction, and go to 1.333 mg/kg and stay there until the MRI shows no uptake in the area of the tumors.

Good data on what you are asking, with the ability for the doctor to contact others who have given treatment is important. I was able to send a message very high up in the organization that treated my wife. Mario had approval for the clinical studies for Carol. Sometimes all it takes is the physician knowing that you will do it with or without them to get approval.

Good luck and let me know if I can help.

Paul

[marvass]

Thanks Paul

Mario

[marvass]

Update:
Till now 10 IT herceptin procedures, started at 30mg and escalated to 100mg. Last 4 of 100mg together with 50mg IT hydrocortisone per week through lumbar puncture, no radiation or chemo. My wife is still doing fine, living a normal live. MRI to check if the brain lesions are all gone in about 2 weeks, will let you know results as soon as possible, but I can feel like I know what the results are going to be! Fingers crossed I'm right.
Mario

[ehower]

Mario,

I think you told me you were in NY. Is that true? I'm in PA and can't get my area doctor to do IT Herceptin. My lesion is on my right cranial nerve and I have double vision. I am undergoing radiation-- on day 2 out of 15. No luck so far. The docs don't know if my eye will ever recover. It's visibly misaligned and I'm struggling to perceive my world in a visual fashion. If you could let me know where you're going, maybe I could go there, too. My doc says there is only anecdotal success-- a patient here and a patient there. But your wife and Paul's wife might be in one of those antecdotal stories. I'd like to be anecdotal storie, too!!

Thanks for sharing the good news about your wife. I am very very happy for you. xoxo Eileen

[marvass]

Yes we were in NY till 3 months ago but had to travel back to Europe to get the treatment done at our homeland, by our oncologist here, since I could not find anywhere in the states except the chicago trial, and this was taking time. Thanks for the good wishes. I think Paul can help you out to be another antecdotal. Just get in touch. Good luck Eileen and don't give up, fight for IT till you get IT. As far as I know, all that tried IT got cured.
Mario

[NEDenise]

Eileen,
I'm in PA too. I've heard rumblings that there may be a trial site in Pittsburgh opening up in Aug. Boy, I hope that's true! Pittsburgh would be VERY do-able for me...I have family near there.

I'm due to have gammaknife on Aug 10th...then I'll go from there.

Best of everything to you! and Nina and Carol too, of course!
Denise

[marvass]

Thanks denise for the wishes to Carol and Nina, and for the wonderful news of this trial. Wish you a quick recovery.
Mario

[schoonder]

Searching clinicaltrials.gov with intrathecal and trastuzumab as search key provided this as the only link to stateside trial.
Don't know how much "anecdotal" data from this evaluation has been published, if any, I hope that it was all positive.
Details of trial and contact particulars can be found at:
http://www.clinicaltrials.gov/ct2/show/NCT01325207?term=Intrathecal+Trastuzumab&rank=1

Hope this little bit of info was helpful.

[marvass]

Those are the two trails going on at the moment since last year, one in Chicago and the other in France. A lot of talking is going on at the moment that new trials are going to start soon, but still there is nothing new listed in the trials sites. Thanks schoonder
Mario

[ehower]

Thanks, Denise!!!! I wish you the very best. xo Eileen I'll let you know what happens with me!

[ehower]

Thanks, Mario. You're giving me a reason to hold on....

Eileen

[KDR]

So glad to hear the good news. May it always be so.
Karen

[hutchibk]

http://www.brainmetsbc.org/index.php?q=node/44

[Rolepaul]

That website is not very comforting. I read it a few hours after we found out about the disease going from the brain to the spinal nerves. All it did was inspire me. Based on that work, both Carol and Nina should have given up. Neither did. Things are moving faster than many of our knowledge leaders can keep up with. I do not agree with the articles assessment, but respect the author's interpretation of the most frequent result.

You can stay in the box, go out side the box, or stand on the box so your voice carries louder. Guess which I am?

[ehower]

I agree. I was very depressed after I read this article....

[ehower]

Paul- or anybody out there.... My cancer has spread to the 6th cranial nerve which controls vision. I now have severe double vision and am cross-eyed. Very difficult to handle emotionally. I am going through radiation to try to stop the progression but it's not repairing the double vision. I have talked to my doctors about intrathecal herceptin but have gotten nowhere. I know I can't travel to France or IL to get the treatment. I'm going to try one last time with my oncologist on Thursday to see if he can contact the doctor at MD Anderson. I've fared through this whole cancer ordeal so well, but this has really got the better of me. Thanks for your encouragement. I need it so much...

Blessings,

Eileen

[Pray]

Eileen, My heart goes out to you. I am hopeing and praying all will go well for you. I don't know your whole story but if this helps the have been lists recently that here of people who will supply you with airfare and hotels to get you where you need to be to get the help you need. Gods blessings to you and your family, you are quite the fighter! Hope springs eternal!

[NEDenise]

Eileen,
I'm so sorry to hear about your vision. One of my lesions is in the "vision center" of my brain too...and I'm dreading the side effects that may ensue.

If you don't mind my asking...where are you being treated currently? If you'd rather not post publicly, PM me. I'm wondering if you might not be near enough to one of our major cancer centers in PA to get a consult. Heck, depending on where you live in this great big state...you might even be closer to one of the other "majors" in a neighboring state.

Loyalty and trust are important...but sometimes that second opinion is the one that makes the difference. In our current situation...time is definitely of the essence! Wait and see? ...that's not an option.

Praying for you, and sending love through cyber space!
Denise

[Rolepaul]

I am trying to help Eileen, Denise, and Ashley. This is getting frustrating. Is it time to get some push in the media? I made a first inquiry, now I need to move it up to the next level. How about getting some push from the group here with your DC politicians to get some movement? The doctors want to do it, the patients need it, but the paperwork to do it is tremendous. MD Anderson wants to get a multi-center study going, so I am going to be there on Friday to do the necessary part from the patient's side to get this going. I have a VP at Genentech/Roche that I might need the help of this group to put some pressure on. I will give him one more chance to do the right thing, then we group up or move it up a rung. Genentech/Roche made a lot of positive points with Pertuzumab approval, lets give them a shot to do the same with this approved drug and an approved method. I have to see what it takes to move this from "Compassionate Care, off label use" to "New indication". I still have a contact or two that I have not used yet. I heard Ashley in Nashville got approval. Time to lawyer on a few more doctors. The time to do IT Herceptin is now, not two to five years from now.

Ants can get elephants to move. This just have to act together. Lets be Ants.
Never give up.
I hate to lose.

[ehower]

Hi, Denise,

I'm in Bloomsburg, PA and being treated at Geisinger Medical Ctr. I like everybody there very much, but I'm feeling like my situation (with leptomenegeal disease, double vision, etc.) is impelling me to look toward IT Herceptin. Paul, you're an honest-to-goodness go-getter, and I can't thank you enough for all your work and dedication. Thank you.
Eileen

[marvass]

Hey Paul, I don't know how to thank u enough!!
Denise, Ashley and Eileen, I did dedicate 3 weeks full time 24/7 running around, asking everyone to help me. At first I found all doors closed, but with a good fighting spirit I finished up able to do IT herceptin in 3 places, Chicago, France and my homeland, while my wife was still in NY. It was a hard 3 weeks, and every day I felt stronger. And with Paul's help I would have had MD Anderson soon. If I didn't succeed I would have tried California too. But then we choose our homeland and immediately started in a few days the first procedure. If you want IT I'm sure you can get it and if you don't find in the states you have to find anywhere in this universe. After all you have a right to get it once it is there and it is curing people. So be strong. Wish you all a very quick recovery.
Thanks Karen for the good wishes and for your help, Brenda and Denise
Mario

[Rolepaul]

Mario,
Drink a toast of champagne for me with Carol. Happy Anniversary! The next ones will be even sweeter. Here's to good MRI scans for Carol next week.

I will do any magic I can to help, particularly with HER+ brain mets. I do not like being told no, and neither did Mario. Save your life or help a family member save theirs by investigating, making a choice on treatment, and going forward. I am backing Intrathecal Herceptin for Brain/LMD/Spinal nerve mets until a better choice comes along.

I think I am getting on the back of the dragon in South San Francisco. They are trying to see who I am through some of their contacts, but none of those who know me are saying anything. Let's see if I can get in the saddle and steer the dragon the way I want. I will let you know more soon.
Paul

[StephN]

RIDE 'EM cowboy Paul!!!

Let us know what we can do as a group.

[NEDenise]

Paul,
I'm with Steph and Eileen...THANK YOU for all you're doing! And please...if there's something we can do, as a group, or even as individuals...I know I'm on board, and I bet a lot of our friends here would be willing to help too.

Eileen,
Geisinger has a good rep. I know at least one of the docs who treated my mom, at Fox Chase, is there now. But sadly...it's not where the IT Herceptin trials are...so it sucks either way.

Happy Anniversary Mario and Carol! And many, many more!

Denise

[Rolepaul]

Eileen,
I am hearing that there might be some movement in that area. I just need to help push it just a little more. I think I need to get some info from MD Anderson to the doc.

I will do what I can for all out there. Still waiting to hear from a certain contact that took my email and said they will get back to me. I am going to see Nina tomorrow night. I will follow through on emails when I can.

[marvass]

Thank you all for the good wishes, we did enjoy a good anniversary, and we are confident that there are more and more to come.
Mario

[marvass]

I would like to clarify the title.
My wife had Leptomeningeal Metastases, that is, many mets on the lining of the brain, the meninges, together with one 2 cm met on this lining. This was begining of last year. However after treating with local radiation and stayed clear for about a year, this developed into many mets inside the brain tissue, 6 at least varying from 6mm to 3mm, and countless others that were just about beginning to be visible. So actually this was no longer Leptomeningeal Metastase but brain tumours. IT herceptin alone is good to treat this in Her2+ and till now (3 months from being diagnosed and started treatment with IT) we had good results. She did no more radiation and no chemo. I have read that some tried it even with triple negative and worked.
I just wish that we had done this at the beginning of the cancer, while taking adjuvent IV herceptin after the masectomy, I'm sure none of this would have happened 3 years later!! She was stage 3, so those of you being stage 3 take my advice, do some IT herceptin shots through lumbar, not just IV, if you can.
Mario

[hutchibk]

Apparently my post disappeared, but if I am not wrong (and often can be), IT is available anywhere that you have an Onc who does it and insurance covers it. You don't have to find a clinical trial. I have had one friend consider it locally, and one on the west coast who had it.

And, great advice about lumbar shots as opposed to IV, Mario.

[ehower]

Paul, Somehow I missed this post. I just found it. thank you!!!!! You're so thorough. I'm going to my onc on Tuesday and begging him to take a look at this procedure. Thank you so much. Thank you Paul, Mario, Carol, Nina, Brenda!! xo Eileen

[ehower]

Paul, I referred in the last response to your post about yours and Nina's story. It just didn't go under the proper posting...

[marvass]

Good luck Eileen, wish you get what you want.
Brenda, this is still not a standard procedure, so all this depends on your onc.
Mario

[marvass]

MRI of 2 weeks ago came out to be not as good as we expected. The 6 tumors that were present before stayed the same size, however there are some new small spots around the brain and so most probably this dosage of 100mg IT herceptin is not working to clear all. However doctors said that they are not certain that this means progression, it could be that this new spots are herceptin marks on the cells that were present. Now the dosage has been increased to 150mg IT herceptin together with 50mg steroid per week. My wife can tolerate this without any sde effects at all. Quality of life is still very good. We are also starting lapatinib as from next week, and then MRI is another 6 weeks or so, to check if the tumors start shrinking.

[ehower]

Hi, Mario, Thanks for the update. We're all thinking about you and your wife. The good news is that the larger tumors didn't grow. I hope the lapatinib goes well, too!! Eileen

[hutchibk]

Thanks Mario... as my quote said, "... it is available anywhere that you have an Onc who does it and insurance covers it." I think that is the same thing, no?

[marvass]

You are both welcome, over these couple of weeks, my wife is still stable with a very good quality of life. Hope the tykerb and herceptine are working, will scan in a month's time and update.

[ehower]

Glad things are going well. Looking forward to a positive next report!!!

[Pray]

I'm hoping and praying to hearing more postive reports! Gods blessings to you and your family!

[evlin75]

IT herceptin is available in Orlando at the MD Anderson facility there, if anyone needing this lives in this area.

[marvass]

That is great news elvin!!

Thanks pray and ehower.

Will keep you updated.

[Rolepaul]

Nina is still doing great. The bump up in Herceptin IT dosage might have something to do with it. There are two small areas that need to be followed. One is in the L2-L3 spinal nerves, but it is really hard to see. The other is on the L5 top plate, but it appeared back in the spring after a really brutal Lumbar Puncture. In the mean time, Nina has been back home since Labor day weekend and then flew out to Houston for treatment, Denver to visit her mother, back to Houston for treatment and eval, then home this past Saturday. She is walking like crazy, driving, computering, yogaing, etc. We are not out of the danger zone, but things are in a comfortable spot. A person from the mid east started her treatment regimen two weeks ago with Nina's method. So there are a few already being helped. Time to see what I can do to get more treated and healthy. Still some reluctance on deep brain treatment, but working on having more women with that issue addressed in the next few months.

[KDR]

Yoga? Fantastic! Thank for the update on Nina and I look forward to more good news...
Karen

[marvass]

Wife is still doing well, MRI this week, will see how the combination of herceptin 150 mg IT every week and IV every 3 weeks together with 1250 mg tykerb worked. We are hoping for better news, fingers crossed.
Mario

[evlin75]

Glad to hear the IT treatments seem to be working for others. My daughter was infected with staph - either when the ommaya port was installed or when herceptin was instilled. Had to remove it in an emergency procedure. Found an abscess behind the ommaya. I stayed with her for eight weeks instilling antibiotics IV to get it under control.
She has since transferred to MD Anderson in Orlando whee she is getting the IT by spinal puncture. 40 mg right now, but can be raised -unlike the clinical trial. The clinical trial dose would not change. The first MRI showed clearing of the cervical area and other areas with a bit less of the cancer. The second MRI looked mostly the same with not much change seen.
The fact that she was infected and could not receive chemo for the other areas of her body - bones etc - allowed her to qualify for the pertuzamab. She said maybe the infection was a blessing in disguise.
She has remained on the Tykerb and is now back on the Herceptin plus pertuzamab also.
I am keeping my fingers crossed that this will work for her and am wishing the best for all - no matter the diagnoses or treatments scheduled for them.

[Pray]

Mario and Evlin, I am always hoping and praying for good results , Gods blessings to both of your families.

[ehower]

Mario, Let us know the MRI results. I'll be thinking of you and your wife. I'm sending along my best wishes for only good results.

Elvin, I'm glad things are looking up for you daughter and hope that trend continues.

Eileen

[marvass]

Thanks all of you MRI is tomorrow, will post here
Elvin, my wife also got an infection through the lumbar puncture and had very high fever and was hospitalized for a week to get intravenous antibiotic and emergency meningitis treatment, but she responded very well and fever got down in a couple of days.
For tomorrow,
Mario

[marvass]

MRI results of my wife:
Most of the mets are gone only a few left, even those that were deep brain ones.
An edema is still visible with same contrast but swelled slightly.

Seems we are getting somewhere at last!! Thank god.

Mario

[evlin75]

Wonderful! Great news.

[turtle]

SO HAPPY to hear your news- may it continue. hang in there!!

[Pray]

How wonderful for you both! Gods blessings to you both!

[marvass]

Thanks to all
Mario

[Rolepaul]

My thoughts are with you and Carol. I hope you have similar results to us. Nina is still getting lots of chemo, but with the overwhelmingly good results we are hoping to get to once per month on IV and IT. Seven months since anything confirmed as disease in either the brain or spine, although there were scares in August and September. Mario, we are hoping for the success Nina has had. Keep posting and all the good feelings from this site will carry Carol along.

[marvass]

Thanks Paul. Looks like we are closing in too.
Regards
Mario

[marvass]

Doctor asked to start Xeloda too!! Is there any issue that anyone knows of when taking Xeloda with Herceptin?
Carol still doing fine but it is taking a bit long to clear the brain completely from cancer cells, and this is the reason why Xeloda, Tykerb, IT IV herceptin are being considered.
In last MRI most of the tumors were gone but the edema that is left at an outskirts part of the brain is worrying. At least this is not deep brain like the ones that are now cleared.
Wish us luck.
Next MRI in a month's time, will keep you updated,

Mario

[evlin75]

My daughter took xeloda with herceptin and tykerb after brain surgery followed by WBR several years ago. There was no negative interaction in her case. The xeloda did not seem to do anything for her and was discontinued.

At this time she is getting the IT therapy with herceptin 40 and topotecan weekly- and also IV therapy with herceptin and perjeta every three weeks. She continues taking the tykerb.

The cervical area of the spine mets has resolved . The other spine mets are stable- basically no change There is a questionable spot on the brain yet. The next MRI is in two weeks.

She started out in Chicago in August with just the low dose of 10 twice a week on the Herceptin IT. She has been on the 40 for a couple months. We are trying to persuade the doctor to up the dose of IT Herceptin. He will decide what to change after the next MRI.

[marvass]

Thanks Elvin for this information. Wish your daughter gets quick recovery.

My wife (220 lbs) is now taking:
IT herceptin 150 mg, IT steroid 50mg, once every week (since 6 months ago).
4000 mg Xeloda (starting now) and 1250 mg Tykerb (since 3 months ago) every day
4 mg steroid orally every day
IV herceptin 600 mg every three weeks (since 2 years ago when one 2cm met was found for the first time and was locally irradiated).
She is not showing any progression and most of the contrast areas in previous MRIs are gone, even deep brain mets. Only an edema which was present in all previous MRIs seemed slightly swelled, and this is the main problem left.

Will update after next MRI in a month's time.

Mario

[Rolepaul]

Mario,
Xeloda can cause her hands and feet to have skin issues. Look at Monique Doyle Spencer using Henna for Hand foot syndrome. Also Vitamin K cream on the hands. Nina did Udder Cream and Bag Balm, one of those during the day and one at night because she did not want the yellow hands from the Henna. But she yellow footed so she could walk without pain. Henna is Clinical trials for this, but Vitamin K cream worked almost as well.

[marvass]

Thanks Paul, you are always a great help!

Mario

[marvass]

MRI of this week:

Edema is less than half it was two month ago.
All tumors gone except for 3 small ones now measure 4mm or less. These were around 6 to 7 mm 4 months ago.
All the tumors that were gone in the MRI of two months ago did not show up again in this new MRI.
Looks like we are getting very close to clear all the brain from this metastatic cancer. Maybe with next MRI end of next February, fingers crossed.

Mario

[yanyan]

That is great news Mario! Very happy for you and your wife !!!

[Rolepaul]

Mario,
Sounds great. I hope the steroids are keeping down the side effects. Nina is doing excellent and we might be getting some traction on getting others treated. I am working on how to get contact with some people to get funding for 200 patients. Nina and I were invited to meet with the president of a major pharmaceutical equipment supplier to tell our story for the first time in public. I am trying to see what my new company will let me do. Boulder Colorado is the new location to be with Nina's parents and other family members. We lived on the other side of Denver previously, so it is good to go back home. Nina is sore in the legs, possibly from nerve damage, so she gets a massage from me every day. It is very helpful to her and I like the feeling of her skin on my hands.
Christmas was special. She was not supposed to be alive, so it was truely wonderful to be in Colorado. I had called a company and they made a job offer that will work. It also might let be more outspoken than my current company.
Merry Christmas to you and Carol and a Happy New Year. A year from now you will both be celebrating as we did.
Paul

[marvass]

Thanks to both of you, yanyan and Paul
Great to hear the good news of Nina, wish you luck.
Happy new year to all of you.
Mario

[yanyan]

Hi Ev ! I hope the loaded dosage will do the trick! You are such a wonderful mom! My mom flew all the way form china and is staying with me again for 5 months to take care of me! I just wish I dont have to put her thru this. Many times our care givers or close ones suffer more than us the patients emotionally. I can't imagine if my daughter ever had to deal with this. Hopefully they will soon find a cure for cancer. Blessings to the ones that support us with all their love!!

[StephN]

Anyone on this? It opened last April - at Northwestern, Chicago.

Prot# H4320//NU 10C03: Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer

Hugh Anderson; Mary Cianfrocca; William Gradishar; Sean Grimm; Virginia Georgia Kaklamani; Jeffrey Raizer
4/22/2011 - 4/22/2014

Sponsoring Organization:Genentech, Inc.

[marvass]

Hi Evlin
I am no expert on these chemicals, all I know that 90mg seemed to stop the cancer grow but did little to cure it, with 150mg we are seeing very fast removal of these tumors, and 150mg were perfectly tolerated by my wife, so there should be no problem by escalting the dose slowly, even above 100mg. Wish you luck
Mario

[evlin75]

Due to the atypical cells showing in the spinal fluid, the doctor set up the treatment for Herceptin IT 60 mg. instead of the 50 mg he had originally agreed was a next step. Not completely theraputic mg per kg for my daughter but a step forward to getting there.

She tried adding Tykerb back into the mix but had N/V so had to go back on her nausea medication. Stopped the Tykerb again.

She is scheduled to get the Ommaya replaced in a week or so. Hopefully that will aid the profusion to more areas of the meninges.

So far this has been an "uphill and against the wind" battle but we are keeping hope alive.

Ev

[Joan M]

This is a long thread, and I'm not sure whether anybody has realized that Sloan-Kettering is also conducting such a trial:

http://www.mskcc.org/cancer-care/trial/12-123

Joan

[evlin75]

I looked up the protocol at Sloan Kettering and it seems quite in line with the Chicago trial my daughter Susan was in for a short time.
Some get higher doses than others but go only to 40 mg.
The routine is usually 10 mg twice week for the first month.
The dose not large enough to work for my daughter even at 40, so she is being given 60. Higher doses seem to be needed to clear the meninges.

Thanks for the info. Getting clinical trials started though is progress.
Ev

[marvass]

Yes, Sloan is part of the Chicago trial, on same principles. You can view here.

http://clinicaltrials.gov/show/NCT01325207

Twice a week at 40mg is equivalent to 80mg a week, so it is not such a low dose. My wife is still doing 150mg IT herceptin and 50mg IT steroid a week through lumbar puncture, with no side effects at all.

Wish you luck Evlin.

Mario

[evlin75]

Some were started at the lower dose without any hope of that dose escalating. My daughter was selected to stay on the lower dose and continuing that dose throughtout. That is the main reason we sought out another source to allow excalation of the dose.

This is a very diffucult business as we know the timetable for Leptomenigeal cancer is short if the dose is not adequate.

We are bit discouraged right now since the last two spinal cytology showed atypical cells again. A lot of treatments, MRIs and traveling to appointments taking up most of her life without mesurable change and improvement in the MRI views of the cancer cells in the spinal cord.

It is a great positive though that the physician has finally gone to 60 mg.

We need some good news right now though, and signs of some reduction of the cancer cells.

Ev

[Rolepaul]

Ev,
Keep pushing for Susan. I talked to her on the phone in July and was told that things were going downhill quick. Keep talking to doctors. The dose that seems to be effective is 1.5 mg/kg of body weight (ie 150 mg for 100 kg or 220 pounds in Malta for Carol, 90-100 mg for Nina at 63 kg or 139 pounds), etc. The lower dosage may be why other patients only put the disease into hold. There is good evidence that it works even on lesions that are up to 4 cm below the surface of the brain, although the response time is up to 60 days. Keep on fighting for Susan. I am getting settled in Boulder and have started the new job. With a little more travel away from home, this forum will get my attention a little bit more. Nina is seeing her mother every day as we are staying there until we close on our new house. Last January and February we struggled to get to these levels, but by April things had turned around. Keep kicking them in the shin. If nothing elsee, give me their contact info and I have bigger shoes than you!
From a happy and healthy Nina and Paul the driver

[marvass]

From our MRIs at 50mg IT herceptin we already saw that the cancer did not grow more, for 220 lbs mass, so in your case I think that with 60mg you should see shrinkage. But if you can get more without any side effects I think that you should keep pushing once you settle at 60mg, I am sure the doctor will agree to try 70 or 80, if there are no side effects at 60. Wish you luck Evlin.

Mario

[KDR]

I have been watching the stories on these threads on IT Herceptin and have to say I think you are all so brave and thanks for being out there for all of us who might need this type of treatment in the future.


Karen
Treatment: Memorial Sloan Kettering Cancer Center (NYC);
World Trade Center Survivor (56th Floor/North Tower);
Dxd: June 2010, liver mets. ER-/PR+10%; HER2+++.
July 2010: Begin Taxol/Herceptin.
January 2011: NED
April 2011: Progression in liver only. Other previous affected areas eradicated. Discontinue Taxol/Herceptin after 32 infusions.
May 2011: Brain MRI: clear.
May 2011: Begin Tykerb daily, Xeloda twice per day for one week on, one week off, and Herceptin.
June-October 2011: CEA in normal range. PET/CT stable; no new lesions.
November 2011: Progression in liver. Previous tumors remain eradicated.
December 2011: Begin trial: 09-093 Taxol, MCC-DM1 (T-DM1), Perjeta. Brain MRI: clear.
January 2012: NED. Liver mets eradicated.
March 2012: NED. Taxol removed from regimen. Continue Protocol of T-DM1 and Perjeta alone.
May 2012: NED.
June 2012: Brain MRI: clear.
June 2012: NED.
August 2012: NED.
September 2012: NED.
October 2012: NED.
November 2012: NED.
December 2012: 09-093 trial concluded; enter trial extension 09-037. CT, Brain MRI, bone scan: clear.
January 2013: NED. Forever, please.

[marvass]

Thanks Karen for your continuous support, surely we are trying a treatment that will cure thousands in the future, especially those that had their lymph nodes tested positive on detection of the first breast cancer. But we are not the pioneers. I did follow some that did it years ago and got to know this from Courtney L., who did it two years ago, and worked on her too to clear her brain from tumors, sadly she had other places with tumors. I am so grateful for her. Nowadays it is not that difficult to find a way to do it, since now it is available in many places, even at Sloan Kettering in NY.

Mario

[Rolepaul]

We agree with Mario. The people that are getting treated now owe their lives to Courtney, a woman in Germany, a UCLA patient who is four years into good health, to a woman in Japan, to two women in Eastern Europe, and to those that have gone to Chicago and Sloan Kettering. The cases are out there, and some of them are very scary. There is no way to know the fear that they had. There is also no way to thank them for overcoming that fear and taking the risk. We firmly believe that Nina is alive because I could access their information and make some judgement calls. We cannot thank MD Anderson enough for allowing the treatment to occur. We cannot thank Anthem BCBS enough for the coverage they have given us, and the support to take the stress off our minds in terms of financial impact for the treatment, and we cannot thank Genentech/Roche enough for supporting IT Herceptin treatment development. Lastly, and most importantly, I personally cannot thank enough the members of this forum for their support emotionally as this was a very hard year. For 8 months, Nina and I would get together every other weekend, but the times in between were mentally challenging. This forum provided me with something positive to do, a place to put my thoughts, and calm my fears. Keep up the great work for all of those who read and may or may not contribute themselves.

[marvass]

Carol is still doing fine, today is her 47th birthday and is enjoying it to the full!! Will have an MRI in 2 weeks and will post results here.
Mario

[dchips1]

YEAH, HAPPY BIRTHDAY Carol, You are such an inspiration to others, Have fun.

Prayers for continued healing and Improved scans and MORE BIRTHDAYS!!!!

Darita

[NEDenise]

Happy Birthday, Carol!!

I hope we're both around to celebrate your 57th, 67th, 77th.....

Denise

[evlin75]

Hope Carol has many more occasions to celebrate. My daughter felt she had accomplished something of importance when she made it to her 50th this last year. With this new IT treatment we have renewed hope for many more birthdays.
I hope there are many more birthdays for all.
Ev

[marvass]

Thank Denise, Darita and Evlin for your good wishes!
Happy Valentine's to all.

Mario

[evlin75]

Susan's MRI is showing some type of increased activity. Could it be from the lumbar puncture truma? We were so hoping for some irradication signs in this last MRI.

At least the Ommaya is now in place and she won't have to use the lumbar area from now on.

[marvass]

Carol's first MRI also showed increased activity, only after her 2nd MRI had it settled. I think it is the herceptin working on the cells and had happened with my wife. It takes time.
Mario

[evlin75]

She was at 40 mg several months. Then she rceived 60 mg x four and then 80 x one and this is not just the second MRI. I am just hoping against hope that this is just activity from destruction or possibly truma from the several very difficult and painful Lumbar punctures.

[marvass]

But Carol's dose went up very quickly, if i remember correctly with the 14th dose we were already at 100mg, and MRI still showed more new spots inside the brain on the 2nd MRI after the 14th dose, then went to 150mg and after 22 weeks it just settled. With 40mg I doubt how much was it working, but with 80mg it is going to work and you will see the result over the next 2 MRIs. I don't think that doing lumbar instead of ommaya does much difference.
Mario

[marvass]

Just checked the threads, Carol went to 90mg in 6 weeks, then 100mg for another 8 weeks, on the 14th week MRI showed some new spots, then escalated to 150mg, then results started to show, with 3rd MRI 22 weeks after starting. So that is long!! Be patient Evlin, it is going to work.
Mario

[evlin75]

Mario, Could I ask where Carol recived her IT treatments?

[marvass]

We are in Europe not US.

[marvass]

MRI and CT scan this Tuesday, fingers crossed. Will post results as soon as I can.
Mario

[marvass]

MRI and CT scan of yesterday:

Edema is stable just like it was two month ago.
All tumors gone except for 1 small one now measuring around 3 to 4mm diameter. There were 3 deep brain ones left 2 months ago.
All the tumors that were gone in the MRI of two months ago did not show up again in this new MRI.
Looks like we are getting closer and closer to clear all the brain from this metastatic cancer.
CT Scan came out good, there are no tumors or activity all around the whole body except for this last tiny deep brain tumor.
Thank God!

Mario

[NEDenise]

Mario!
Thank God indeed!
I couldn't be happier for you, or your beautiful Carol!

Please give her all my best wishes!
Denise

[Rolepaul]

Mario and Carol,
We have not abandoned you, just incredibly busy. Carol's progress is truly amazing and inspirational. I do not know what to say. I am trying to get doctors in the US to treat the same condition and getting roadblocked bad.

Wee know that Carol will show the same positive results Nina did. We have faith in the IT Herceptin and in both of you. Nina is issue free since October 2012, and really for the past 11 months. We hope all enjoy the benefits that the treatment can provide and look forward to hearing of better acceptance within the medical community.

Paul

[evlin75]

Depocyt is what my daughter is receiving IT and it cannot be mixed with Herceptin. Dr wanted to take her off Herceptin, but I feel it still can work now since the ommaya is in place. Maybe the LP did not give good perfusion. The Depocyt can b given every two weeks and then even farther apart later. The reason we had to go to it, is there was much progression and we needed to have some immediate relief. No obstrutions yet and that is good. So she is getting the Herceptin on alternate weeks.
The Depocyt is caustic and tends to inflame the tissues so steroids are also used. My daughter did have quite a reaction with the first treatment and was hospitalized to get it under control. The doctor then ordered more coverage of the steroids.
A VERY difficult nd trecherous path but we still have hope of knocking this down.

[Rolepaul]

The ability to decide on what path to take for treatment is difficult. I do not think that there has been a suitable dose to allow successful treatment at the 80 mg dosing. We did not see progress with Nina until there was 10 doses at 80 mg for 62 kg Nina. We actually saw additional improvement at 100 mg for 65 kg. This 1.5 mg/kg dosing was also important for Carol, Mario's wife. It does not occur in 2 weeks, but in 10-16 weeks. It should however, stop progression of the disease immediately. Any edema is probably due to the cancer cells dying. Do not give up. Depocyte is really hard on the brain. I am in the business of making these drugs, you want to use a monoclonal Antibody if at all possible.
Superior Paul

[evlin75]

Hi Paul,
We sure did not want to go to this, but the doctor said it had increased along the spine all the way plus extra growths in the lumbar, thorax and several in the cerebellum. He said he was afraid it was going fast enough that it might get past his ability to handle it.
Hopefully we can keep adding the Herceptin and increase the herceptin as the doses of depocyt get further apart.
He said the herceptin with the topotecan was not working.
Thanks for the input.
Ev

[Rolepaul]

My thoughts are with you and Susan. I think the dose was not strong enough for the Herceptin plus Topotecan, but the doctor is there and it is his job to be right.

[marvass]

Wish you luck Ev and Sue, thank Paul, I know you were so busy lately.
Mario

[marvass]

Last Thursday my wife had a seizure which was not strong, but could not go away. Had to take her to emergency and even with 20mg valium could not stop, well it took over 4 hours to control, but still she is having twitches in her hand, continuously. Looks like she has some damage now. A scan done yesterday resulted in that there are no brain hemorrhage and that no more tumors are visible except for the edema that she had. She is on 6mg steroids (dexametasone) and muscle relaxants (ativan and rivotril), plus 3000mg keppra and 300mg epanutin daily but still with these continuous twitches. Don't know what to do. Anyone has an idea?

[dchips1]

i had stroke type symptons in 2010 that said was steroid related. prayers for continue healin Darita

[NEDenise]

Mario,
Sending prayers too...hang in there.
Denise

[Rolepaul]

Mario,
Not sure what to say about this. Our thoughts are with you and Carol. I wonder about the steroids issue as well. I think you are on the right track for treatment. I hope this is just a short setback.
Paul

[marvass]

Thanks all of you for the good wishes.
Fits nearly gone now, only slight ones once or twice a day, lasting less than a minute.
She is now on Keppra 2500mg daily, Epilim Chrono 800mg daily, Phenytoin 300mg (which should be reduced this week) and 9mg dexametasone.
Mario

[marvass]

Fits still on!!

Don't know what's wrong! neither do the docs!!

She is on 2000mg keppra, Epilum Chrono 2000mg, Phenytoin 300mg and still having slight fits 3 to 4 times a day, lasting a minute or less. Every time she moves slightly without cooling her head. But how come when the cancer is gone! Maybe scars from the past.
Strange and the brain cannot be explained.
Treatment of IT herceptin and IT hydrocotisone and Tykerb has been stopped for 4 weeks now.
Hope nothing goes bad.

Mario

[dchips1]

has she been evaluated by the neurology department? changes in MRI? What does Her EEG show?

Prayers for peace and healing

darita

[NEDenise]

Mario,
Praying for you both daily. Is Carol able to be at home, or is she better monitored in hospital? How is she 'feeling' otherwise?

I imagine this is harder on you, than it is on her. My heart goes out to you.
Sending love and positive thoughts to you both across the many miles.
Denise

[marvass]

Last MRI showed positive results, but she had decreased steroids and this must have increased slightly the edema. Neorology specialist still not seen, trying to do it ASAP, in the mean time she is increasing the steroids again to try and stabilize to start again intrathecal. Thanks Denise and Darita.
Mario

[dchips1]

keep us posted , prayers and good thoughts for healing and answers.

Darita

[marvass]

The last complication that we had was a pulminary embolism!!
My wife is recovering from a very heavy one which nearly killed her last week, but now is stable and nearly cleared. What else can happen to her, God only knows. With this cancer you solve one problem and another props up very soon.

[NEDenise]

Mario and Paul,
Haven't seen an update from either of you for a while.
What news of your beautiful wives?

Sending love and prayers...hoping to hear from ou both soon!
Denise

[marvass]

Hi Denise,
My wife is still doing quite well, but had some brain hemorrhage which resulted in restricted movement of her right arm. Claxane has been reduced after 6 weeks from the PE, it is now down to 40mg per day. Otherwise cancer is under control, edema is still present so most probably it will soon be irradiated locally to kill any remaining cancerous cells. She had restarted IT herceptin 4 weeks ago at 150mg again, after an absence of 7 weeks.

Will keep you posted.

Thanks for asking, Denise, how are you doing?

Mario

[NEDenise]

Mario
So glad to read your update! Any idea from docs whether restricted movement in Carol's arm is likely to resolve over time? Is she right handed? All things considered, it sounds like she made out pretty well. Have the seizures resolved?

I'm doing well! Started Avastin to shrink the radiation necrosis...and so far, so good. It seems to be working. KNOCK WOOD! - Don't want to tempt the fates!
For the first time since January I've been able to start weaning from the decadron without the SEs coming back! As of yesterday, I'm down to 4mg/day. I haven't been on that low a dose since...well...I think it must have been last September...right after the GammaKnife. So, I bet you can guess...I'm thrilled with this progress!

All the best to both of you!
Denise

[marvass]

Great to hear you are doing so well.

Carol is right handed, but there is hope of full recovery, since this was only a contained hemorrhage, cause a small stroke. This needs about three more weeks to clear. IT herceptin is on hold from this week, till this is resolved.
Her seizures have stopped completely.

Wish you luck.
Mario

[dchips1]

I am glad she is doing better, prayers to her and recovering her movements. God bless and prayers to you both.

Darita

[marvass]

Carol had a WBRT last month due to the edema she had which could not go away with the herceptin. She is now recovering from the stroke she had, rehab exercises everyday. Intrathecal is on hold but we will soon restart it. No fits and recovery is a bit slow.

[NEDenise]

Mario,
I wish things were a little easier for Carol. You must both be emotionally exhausted.

Does WBRT stand for whole brain radiation? If so, how does that help with edema? We've been trying Avastin to reduce my edema (caused by radiation necrosis) but no one has ever mentioned WBR.

You're both in my prayers... hoping for easier days ahead
Denise

[marvass]

My wife had a second stroke 5 weeks ago, but now recovery is going fast. She is close to start standing again. Understanding everything and communicating quite well.

Intrathecal herceptin is still on hold, only IV herceptin. Steroids are down to 2mg daily, with no fits recently.

She is doing physiotherapy, OT and speech therapy daily and hope to get her out from the rehab center by end of next month, to come home again after 4 months.

My advise is that intrathecal herceptin works but not on big lesions or a large edema. Radiation is needed on these before IT herceptin clears them completely. On 6 mm tumors IT herceptin works for sure but on a 2 cm edema it does not.

So any of you think that you can get away without doing radiation, think twice. The brain is such a delicate organ and you cannot risk to play with tumors in it for a long time. Strokes are a big risk to life besides that quality of life is reduced even after recovery.

My wife was advised to do radiation since October of last year but resisted it till 2 months ago. But I think it would have been much better if she did it before. 14 months with the edema in her brain were too long.

Mario

[NEDenise]

Mario,
You are both in my prayers every day. I know you're taking good care of Carol...please don't forget to look after yourself as well.

Praying, as always, for easier days ahead.
Denise

[Rolepaul]

Mario and Carol,
Our thoughts are with you and we are glad that progress is finally occuring at a faster rate. I am sorry that the IT Herceptin was not as as effective as it was with Nina. Toptecan was added at 0.4 mg with the IT Herceptin and that might have made the difference for our family. We have followed your struggles and hope that there is continued progress.

Paul and Nina

[marvass]

Paul, you did local radiation before starting IT herceptin, we did not. On small tumors it worked but not on the 2cm edema. Otherwise IT herceptin cleared over 10 tumors of 7mm or less.

Topotecan might have helped too, but I think that not doing radiation on the edema for such a lengthy period was a big mistake and Carol paid the price! But it looks as though the radiation now cleared the edema for we are at 1mg steroid only going to zero this week. Next follows an MRI and most probably we restart IT herceptin by end of next month.

Thanks for all your help and support Paul and wish you and Nina all the best.

Thank you Denise for you support.

Regards
Mario

[kaiulanis]

Hi,
I just joined and am fascinated. I have HER2+ leptomeningeal and probably brain mets, just discovered, very early. I've been able to put together Carol's story from Mario and have scattered useful tidbits from Paul but would love a nutshell diagnosis, treatment, result, prognosis timeline history of Nina. And Mario, Evlin, any details you can provide that would help persuade my doctor to try IT Herceptin? I sincerely hope everyone is continuing to enjoy relatively (it's all relative now isn't it?) good health. I don't have any edema and would like to go straight to IT Herc and skip WBRT but maybe you wouldn't agree? It's just that after being the hairless wonder, it came back curly, and I have this fabulous goofy hairdo that I'm loathe to lose. I hope you're still out there listening.

[Rolepaul]

kaiulanis,
This is a tough situation to be in. As Mario indicated, I think zapping the tumors locally and then introducing the Intrathecal Herceptin is probably the best method to do things. The results have been very promising so far.
I would have your doctor talk to Dr. Amal Melhem-Bertrandt at the Breast Cancer Center for MD Anderson Cancer Center in Houston Texas. There is ongoing work to show that IT Herceptin does remove the tumors in the brain and spine, but only when the Herceptin levels are higher than is being used for the Clinical Trial by Dr. Razier at Northwestern Hospital in Chicago (and Sloan Kettering in New York). I would ask for a Compassionate Use (or Compassionate Care) protocol to be started. This is done by having the doctor go to the Internal Review Board of the hospital. Once it passes there, the doctor goes to the drug company (Genentech/Roche in San Francisco) and they approve it, followed by the insurance company. Typically the IRB is the tough place, as Genentech and the insurance company will both approve this treatment. Start at 40 mg per week for four weeks, then go to 1.3 mg/kg of body weight. This will seem high, but clearing of the drug from the spinal fluid is very quick, with a half life of 36 hours or so. They can then follow the tumors being broken down in MRI scans every four weeks, follow the spinal fluid protein and glucose, and by the symptoms becoming less pronounced (walking, headaches, etc.). Let me know if I can do any more.
Paul

[kaiulanis]

Thank you you're the best! Unfortunately, or fortunately, I don't have any symptoms. I just figured my chances are better starting it earlier since it's apparently inevitable. Do the wheels have to be falling off the jalopy before they'll consider it, d'ya think? Pitching my doctor today. Thanks again for your help and all your trail-blazing. I hope your darling Nina is doing okay? Is she still doing maintenance IT Herceptin? NED? SE-free? I'm sure my doctor will ask.

[Rolepaul]

Nina is doing great. We went to once per two weeks for six months and are now at once per four weeks for the past year. She also does IV Herceptin once every three weeks.
NED in MRI scans, PET scan, no cancer cells in the Spinal fluid, with the protein and glucose in the normal range for the spinal fluid. There were no side effects, and steroids were not necessary. We hit the tumors in the spine with radiation before the first IT treatment, but no rad since then.
Nina walks 5 miles per day. She is on the computer, reading books, and helps her mother with her daily activities. She is able to drive, get on the plane to Houston for IT treatment, and make critical decisions on her own. She is looking at restarting work with either RN or Massage Therapy, as she has license in both. There is some pain in the lower back, legs, and some ankle areas, but this is minimal. In other words, she is normal.
I wish you have the same luck. We were very persuasive and knowledgeable, which certainly helped.

Paul

[kaiulanis]

Yay!!!! So so very happy to hear that she and you are doing well. I know what a hard journey this is. PS I'm from Telluride.

Kaiulani

[marvass]

Hi Kaiulani and Paul,

Carol is still doing great, now she can talk very well and she is standing at last, even though she had 3 strokes this summer.
From the experience with the mistakes we did with my wife, I would irradiate the tumors and start IT herceptin as fast as possible, the more you delay the bigger are the chances of complications like my wife had. She has not done any intrathecal for the past 6 months and still all MRIs she did lately showed no signs of any tumors at all. Wish you luck. 1.5mg per kilo of IT Herceptin once weekly together with 50mg hydrocortisone seem to work on patients that Herceptin worked everywhere else except their brain.

Paul I am so glad Nina is still doing fine, good luck.
Mario

[dchips1]

Hi to all off my IT friends, have been doing IT herceptin at 100mg weekly for almost 6 weeks. Still on Tykerb 750 daily as tolerated. IV 105mg Herceptin weekly. Tried a short run of Navelbine, with a negative bone marrow I still have a left shift, (some type of funky immature cells) in the cbc every week. Changes in CBC started with navelbine so that was a short run of that for me. Will redo scans here the next few weeks looking to go to every two weeks by summer if all scans are good. I am able to obtain my Herceptin thru the the mail in pharmacy thru my husbands insurance plan.
Peace and prayers and healing to all

Darita

[marvass]

MRI of this week:
Carol is still NED even now that she is no longer doing IT herceptin for last 8 months.
Seems that damage done with the stroke has opened the BBB for IV herceptin to pass through. She is only taking 6mg per kilo IV herceptin and nothing else. No signs of fits for the past 7 months.
Stroke is clearing but still some old hemorrhage can be seen in it.
She still has quite a good quality of life, but still exercising to start walking again.

Mario

[Rolepaul]

Mario,
Good to hear Carol is doing well. Nina is afraid to stop the IT or IV Herceptin. She is at IV Herceptin every three weeks and IT Herceptin every four weeks. The IV is administered locally and the IT is administered at MD Anderson in Houston.
I think you have a good point about the BBB. It is likely that the IT Herceptin did the job in the time it was administered. The stroke occurring may have been due to the removal of the cancer cells and the collapse of the support system in the brain. That was something I would not have considered a potential issue, but I will forward to others about deep brain lesion potential side effects. The problem is that if the you do not stop the cancer lesions from growing they will kill the person as well. That is something that will have to be thought about by the Brain Cancer specialists.
Good luck. I would love to get out to see you, but it probably will not be this year. I will be going to Hawaii in July for Nina and my birthdays, and then business travel in the Us otherwise.
Glad to hear that Carol is recovering from the stroke. Our thoughts are with you and we hope that your lives are able to return to close to normal.
Paul and Nina

[evlin75]

So glad to hear that Carol is still doing well and gaining strength.
Susan is still getting IT Herceptin 80 weekly. She is now on Abraxine also weekly IV for the enlarged clavicle lymph nodes. The Abraxine is shrinking them and she is doing well on this routine. They did have to cancel one treatment of the Abraxine because of low platelets, but other than losing her hair, she is handling it well and feeling fine.
She has not had an MRI for a while but she is sure feeling much better.
My best to all,

Ev

[dchips1]

Hi Mario I am glad Carol is doing better. Evilin I am glad daughter feeling better as well. Thanks Paulfor leading the way.
I am having surgery to debulk and remove the t 8 lesion and fluid on the 29th. Neuro symptoms are rapidly getting worse. with no quick IT drug available this is what My family and medical team have decided to do. Cool thing is it will be done in Phoenix at Barrows Neurological institute, world class neuro drs and some really good technology and inpatient neuro rehab. since I am already his patient was able to get in very quick. The fluid has pushed the lesion more toward the right side laminectomy style. Best case coming out weak, which I already am, but should stop the growth and stop further nerve damage. Then go back to IT/IV herceptin

Peace and Prayers to all
I will update when they let me have my electronics back!!!!!

[evlin75]

I will be thinking of you on the 29th and am hoping you have great success with the surgery. Will be looking forward to your update.
My very best wishes !

Ev

[Rolepaul]

IT Perjeta is still not in clinical trials. Nina is doing well, but has a spot near where they did the excision and Gamma knife in November 2009. In March 2014, it was a dire issue. In April it was maybe an issue. Last week it was probably not an issue. Stressed out for 60 days needlessly. Back to MRI scans once every two months on the brain and spine. So far so good. I looked at the MRI scans from the past four and a half years (wow...that seems short some days and such a long period other days). I saw slight differences over the past year (one little part looks more nodular), but it might be death of cells (like radiation oncology thinks) versus cells regrowing.

Cigna was being a pain but it was because of a new person approving the reviews. Now that is settled. Still, $4500 deductible before out of pocket max met (did that by February 15). Put $2500 into FSA, but other $2,000 comes out of my wallet immediately.

The Perjeta in the brain using Intrathecal means is still not approved. Genentech will not say why. I hope there were some changes that were to be done in terms of dosing to get to 100 mg per dose. We shall see.

It is strange to be working at the plant that is saving so many lives. I spread the word from this blog on the people that are being treated: The mothers that see their children get married, get to see an extra year of sports, that get to hold their grandchildren, that get to take another trip with their significant others, and that just get to see additional summers. I also talk about the side effects of drugs, the desperation of not having good answers, and reading about the more negative outcomes.

This disease is one I would not wish on any person. We are at the forefront of treating it. There are so many new methods coming down the line that the disease is likely to be put into remission on a regular basis in ten years. Much like patients that were fighting infections in the early 1940s as antibiotic manufacturing start, the women that are undergoing treatment in many cases just need a few more years to get great treatment options. I hope that I can shorten the time for new drugs to market, can inform those with issues of options to get additional quality time, and to be part of the strong emotions that this group gives out.

Keep supporting one another, and I will do the same. Traveling 80% of the time since Jan 13, four weeks home M-F but home every Friday night while leaving every Monday morning, is hard. The benefit is that I should be able to review and respond to emails better.

Fight back. Do not give up hope. Ask questions. Get Answers. The impossible happens because medical care people stay inside the box, some doctors think outside the box, but stand on top of the box and use it to get better and be heard.

[schoonder]

ASCO abstract re: T-DM1
"Author(s): Rupert Bartsch, Anna Sophie Berghoff, Margareta Rudas, Elisabeth Bergen, Michael Gnant, Karin Dieckmann, Katja Pinker, Christoph Zielinski, Guenther G. Steger, Matthias Preusser; Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Institute of Neurology, Medical University of Vienna, Vienna, Austria; Institute of Pathology, Medical University of Vienna, Vienna, Austria; Medical University of Vienna, Vienna, Austria; Comprehensive Cancer Center, Department of Surgery, Medical University of Vienna, Vienna, Austria; Department for Radiation Therapy and Radiation Biology, Medical University of Vienna, Vienna, Austria; Department of Radiology, Medical University of Vienna, Vienna, Austria; Medical University of Vienna, and Initiative “Leben mit Krebs, Vienna, Austria, Vienna, Austria; Department of Medicine I, Clinical Division of Medical Oncology, Medical University of Vienna, Vienna, Austria
Abstract Disclosures (http://apps.asco.org/coidisplay/generateAbstractCOI.aspx?abstractId=134326)


Abstract:

Background: Local treatment options such as radiotherapy or neurosurgery are the mainstay of BM management. Whole brain radiotherapy (WBRT), however, is associated with severe late-toxicity. The LANDSCAPE trial established lapatinib plus capecitabine (LapCap) as primary systemic treatment in oligosymptomatic patients (pts) with multiple Her2-positive BM. Limited evidence exists regarding the activity of antibodies in BM. T-DM1 is an antibody-drug conjugate linking trastuzumab (T) to an anti-microtubule agent. T-DM1 provides activity in pts progressing upon T and has lower toxicity as compared to LapCap. Here, we investigated the activity of T-DM1 in newly diagnosed or progressive BM. Methods: A total of six consecutive pts (median age 55 years) with Her2-positive breast cancer and BM were treated with T-DM1. In two asymptomatic pts, T-DM1 was administered as primary systemic therapy, while four subjects had already received local therapy and had documented CNS progression. T-DM1 was administered intravenously at a dose of 3.6 mg/kg body weight every three weeks; re-assessment of disease status was performed every three cycles. At baseline and restaging, MRI was performed. CNS response was defined as a reduction of lesion size of ≥50%. Results: Median follow-up was 6 months (m) and median brain metastases-free survival 11 m, respectively. All pts had received prior T, three (50%) had already received LapCap, and two (33.3%) pertuzumab. Currently, 4/6 pts (1 with primary treatment and 3 receiving T-DM1 upon CNS progression) are assessable for CNS response. 2/4 pts (50%) had partial remission, while one patient progressing upon prior local therapy had stable disease lasting for 15 cycles. One patient had minor response on MRI but no reduction of pre-existing brain oedema and increasing cortisol doses and was therefore deemed PD. A significant LVEF drop was observed in one heavily pretreated patient. Conclusions: This prospective case series again indicates that systemic therapy offers activity in Her2-positive BM. Currently, LapCap remains the standard of care. Still, T-DM1 offers relevant clinical activity; therefore, the role of T-DM1 in BM should be investigated in larger studies."
http://abstracts.asco.org/144/AbstView_144_134326.html

You're a real trooper Rolepaul.

[Rolepaul]

Pretty interesting as TDM-1 has a molecule that might allow blood brain barrier penetration. It is not good for direct input into the cavity (though an Ommaya reservoir or lumbar puncture) but IV appears to have some benefit. The goal right now is to get IT Herceptin and Perjeta going in clinical trials.

We are on the edge of making this disease go into remission for many women. I just want to say that many of us in the industry want this to occur as soon as possible.

[Rolepaul]

After 30 months, there is some signs of one very small spot on the brain slightly increasing in size when compared versus one year ago. Looking at Perjeta via Intrathecal to address the spot after this long with Herceptin. As far as is known, this would be the first time ever done. If there are not good results, then the spot will get Gamma Knife treatment in November. Otherwise, Nina walks five miles a day, does Water Aerobics, Yoga, drives to the airport, and is generally good shape. Keeping at the cutting edge in the fight against the monster.
30 months after getting a three to six month probable lifespan and still doing the Energizer Bunny routine.
I hate to lose. Never give up.
Paul

[yanyan]

That one little spot hopefully it's just scar tissue. Thanks for the update Paul! Nina's story gives me so much inspiration! From 3 months to 30 months that's a miracle with much love and blessings!

[Rolepaul]

So the good news is that Nina's brain lesion is now called stable. They see incredibly small changes in the MRI scans of her one brain lesion. The docs do not know what it means. The thought is stay the course with IT Herceptin every 4 weeks and another set of MRI scans in 8 weeks. No IT Perjeta because they want to have the IT Herceptin study at Northwestern fully enrolled first. Kind of angry, but I understand.
Spot found on lymph node at top of lung, so told Perjeta/TDM-1/Taxotere. Went with TDM-1 only for now. Nina is going to Italy for 17 days this Saturday so did not want any side effects to slow her down. Another CT scan in eight weeks, next time at MD Anderson, to determine the treatment plan for that one.
Made at people dumping ice water and then donating for research on ALS. How about putting money into the cost of treatment, particularly the difference between the $4500 for max out of pocket and the $2500 for FSA to pay for treatments. Many of the people in the US have a $2000 surprise in February, March, or April as they find out that there is a gap.
Both Nina and I are staying strong. Had 55th birthdays, 19th anniversary, and got our 29 year old son married. None of these would have happened without hard work and a lot of faith from this site. Keep on giving one another a shoulder to lean on.

[evlin75]

Paul,

Best wishes to you and Nina. Susan is still doing the ommaya Herceptin every week. Just finished cyber knife to an enlarged subclavicle lymph node.

Her genome results indicate afatinib or neratinb is appropriate for her because of the mutations found. They are trying for the afatinib first but on first try the insurance has refused approval.

The chemotherapy is getting tough for her - low blood counts and unsteadiness. She has taken herself off of them - hoping for the more targeted approach.

Ev

[marvass]

Carol still doing fine. She started to walk again this summer. She has been off IT herceptin for last 16 months now. Last MRI and CT scan done in May showed she is still NED and stroke clearing more and more. Quality of life getting better day by day. Will scan brain again next week. She is only taking 6mg/kilo IV herceptin and nothing else. Been taking this only treatment for past 16 months now. She has lost 35 kilos in 16 months. Now standing at 77 kg.

[embur102]

Hello everyone!
I am late to this party,
Just found this thread today, 9-6-14.

I was initially diagnosed April, 2012...had R mastectomy May, 2012....A/C chemo July, 2012, followed by Taxol/Herceptin, then Herceptin only until Sept 2013.

Discovered one 2 cm brain lesion in June 2014, following a seizure. No other symptoms. Did one Gamma knife treatment at Cleveland Clinic....follow up MRI showed 50% reduction of lesion, no necrosis, no new lesions. Finished steroids in late July, currently considered "stable" , no symptoms, and scans show no evidence of disease elsewhere in body.

My question is: should I be doing more treatment? (ie IT Herceptin, etc.)
All of my docs are saying "It's all good, could be isolated incident, scans every two months, treat as needed."

I felt ok with that, but now, after reading thru this thread, I am questioning our decision. My quality of life is pretty much normal...I am working, exercising, participating in life as usual, feeling healthy and fine.

Really disliking HER2+ and all of the "grey areas" !!!

Very appreciative of all of the love and support on this board!!! Thankyou!!

[marvass]

If you are her2+ and herceptin is working in all your body except your brain, you may decide to get herceptin to your brain by intrathecal ways. But I am no expert in this. Maybe rolepaul can help you better at this.

[Rolepaul]

We are back and happy. Nina had a subcarinal lymph node that had doubled in size by August. The brain lesion was slowly increasing in size for five years. In August we switched to systemic TDM-1 and continued the IT Herceptin with Topotecan. It appears we have put Nina into full remission. That is beyond anything we could have hoped for. Nina is the only alive of 288 patients with brain/spine HER+ involvement at MD Anderson in the period of 2008 to 2012. As far as we know, she is the only one without whole brain radiation where the disease has been put into remission in the United States. There is hope for success in this area and for a standardized treatment that actually works.

[schoonder]

To you, your wife, and the medical team THANK YOU for how well you've handled this crisis and the progress thus realized. What an inspiration!

[zueoo7]

hello read over the thread quite an inspration I am on the IT study in NewYork MY doc said in last visit That I have slight progression better then when we started in 1/14. Thought the thing to do i find a doc that would do the treetment off study at a higher dose. I did vary well at the start at twice then once a week treetments. Any thoughts where I may find some one????? east coast wold be great///////
thnks ahead of time
zue

[Rolepaul]

I think the IT Herceptin needs to be at least 1. mg per kg to work. Nina's was piggybacked with Topotecan, which may be important (but probably is not). Try Sloan Kettering in New York or ask at MD Anderson in Orlando (Dr. Nick in the Breast Center). Rumor has it that Genentech is looking at IT Perjeta out of Univ of South Calif, but I would not wait. Send me a personal email if you want.

Back for more MRI scans on Dec 13 through 15. Our son's 30th b-day is the 13th. We will celebrate the following weekend if things are good.

[Rolepaul]

Repeat MRI scans show that full remission has occurred. Two residual spots are Gamma knife scarring from December 2009 to a high degree of confidence. Nina is walking five miles per day, is doing yoga four days per week, and is performing all her previous activities without any side effects. First time ever at MD Anderson. I hope this gives a potential road map for others. All it takes is knowledge, determination, and good doctors. Luck was also important for Nina.

[rhondalea]

Stellar news. I just love this thread.

[Rolepaul]

Feb 12 results as good as October and December. That means at least four months (and probably longer) with no brain or systemic disease seen. Almost ready for the happy dance, but Nina is pretty scared. She has five tough years of fighting brain mets (although the last 2 1/2 have been very positive). No spinal disease seen since May of 2012, almost four years. How do I get her to think in terms of ten years out and not two months until the next MRI scans? She is healthy and wants to go give massages to keep her spirits up and help bring extra cash into the house. We can definitely use it.

[yanyan]

Very happy for you and Nina !! Thanks for sharing this great news !!

[marvass]

MRI and CT of today - shock!

3 new lesions can be seen for the first time in over 2 years, 7mm, and 2 others of 4mm.

We have been on IV herceptin 6mg/kg for past 21 months. Now back to problems!

I would like to ask anyone of what can be done except IT herceptin, anyone is doing IT pertuzumab yet?
Does TDM1 work for the brain?

[Rolepaul]

Ask to have 0.4 mg of topotecan in 5 mls of sterile water added to the treatment. Do not use TDM-1 as the non-Herceptin part is too damaging. University of Southern California in Los Angeles is getting ready to run Pertuzumab for IT shortly. Contact them today. Eric Chang would be one of the ones to try to meet.

[marvass]

Thank you Paul, my oncologist in Europe is researching on best way to go, till next week and then we decide from there. Will tell him about the topotecan.

[Rolepaul]

Marvin, I would have them start the Pertuzumab at 40 mg for a few weeks and then go to the same level as you were having done with the IT Herceptin. Also, I wonder if you go back on the IT Herceptin whether that stops progression.

[marvass]

But has it already been tried intrathecally?

[Rolepaul]

No, but I know what the protocol will be. That is part of something not public. It goes along with the Herceptin not tried at the higher doses prior to January 2012 for people like Carol and Nina. I would look at the Toptoecan and Herceptin as the clinical trial might yet be open.

[marvass]

Our oncologist seems to favour for IT herceptin at 150mg again as we did before before trying anything else. Now Carol weighs only 65 kg, so it is a very high dose, 2.3 mg/kilo.

[Rolepaul]

Ask him to think about toptotecan as well. He can ask Dr. Loghin at MD Anderson Brain and Spine in Houston Texas.

[marvass]

First intrathecal herceptin done last friday 6th March after 21 months without any such treatment.

Dose 150mg herceptin and 50mg hydrocortisone.

No pain or funny feelings. All went well, not even painkillers or dexamethasone were needed.

At the moment this will be the only treatment till we scan again in 12 weeks.

Mario

[Rolepaul]

Mario,
That is great news. Send my wishes to Carol.
We are still trying to get to Malta on a trip. I am halfway through working in Omaha during the week and driving home to Denver on the weekends. I get $500 more than it costs, so I am trying to bankroll a trip out of this to Italy.

[Vicky]

Hello,

I was just coming to look for this thread, and here it is front and center. I could use some help!

With a previously treated brain metastasis possibly growing ( unknown if its growth or necrosis) on my latest MRI's, plus a new 9 mm spot very close to it, I am trying to figure out how best to proceed with treatment. I have had stereotactic radio surgery- once to this older spot, and once to another spot that has shrunk.

I mentioned IT Herceptin to my Oncologist, who was very open minded about it. It has not been done in my treatment facility, and he has many questions about it. Is there a doctor who would answer his questions such as dosage, and pre-meds, side-effects, etc.? Or should I seek out going somewhere for treatment? I live on the border of North Dakota and Minnesota, and have had great treatment here so far.

For now they have referred me to a Neurosurgeon for a consult, but I am open to suggestions, any help you can offer. Thank you!!

[Lani]

Vicky leptomeningeal metastases are those that sit on the outer linings of the brain and spinal cord. Cerebrospinal fluid circulates within those membranes.

If your brain mets are not near the outer (or inner) linings of the brain, it is unlikely IT herceptin can get to them as I understand it.

Please be certain to clarify where your brain mets are and how far from the CSF they may lie.

[Rolepaul]

Lani,
Actually, at the doses that were used with Nina and Carol, three of the deep brain patients had good results. It just means that steroids are needed to keep the swelling from causing problems. It is not easy to get patients treated, but there have been three that I am aware of that all had good results. IT does work better on leptimeningeal cases, but there is pretty good evidence that these higher doses are giving positive results as well. As always, Gamma Knife should be the first choice if the lesion is smaller than 2 cm and not near critical function areas. I get information that is not yet public knowledge. That is what I do for a living. There are overseas locations that are not always Medical Industry or medical research friendly until a leader's wife/daughter/mother/granddaughter has an issue.

[Vicky]

Thank you Rolepaul, and Lani for your insight. I appreciate the sharing of info that can me figure out all of my treatment options and to navigate this tricky time as best as I can.

[marvass]

MRI of yesterday:

All three spots gone and none new seen, thank God.

We have done 10 IT herceptin till now each of 150mg herceptin, and 50mg hydrocortisone, each shot every 10/11 days, i.e. 2 times every three weeks. We also did 6mg/kg IV herceptine every three weeks.

Will continue same treatment for another 3 months, and MRI again.

Mario

[thinkpositive]

Mario,

Thanks for sharing your good news! Looks like this treatment is working. I'm very happy for you.

Take Care,
Brenda

[phil]

ASCO last week talked about a promising new tx for her2 , w/ brain mets. a genetic drug - ON380 ( sp. ? ) added to kadcyla. phase I had good results in 8 out of 8 pts who got this combo.

[marvass]

Carol is still doing fine. She now gets the IT and IV treatment of herceptin every 3 weeks, 150mg IT with hydrocortisone, and 6mg per kilo IV. No new mets developed and older ones under control. Hope this ONT-380 with TDM1 gets approval soon. A pill would be much better than IT, with the risks it has, especially with the big risk of meningitis.

It is nearly 5 years now since the 2cm brain tumor was treated with local radio therapy, and 4 years since it come back into several spots again treated locally! It is nearly 3 and a half years since we started IT herceptin.

So those of you fighting brain mets do not give up.

[StephN]

Thanks so much for the update on Carol.
Somehow I have missed ONT-380.
Should we start a new thread and "stick" it for this possibility?

A pill sounds grand. My nephew's wife has just been in quarantine for meningitis and it has been very tough for her as she is a young mother. (She does not have cancer, so I do not know how she got the disease.)

[agness]

Here are some questions that aren't addressed here:

Has anyone who has had IT Herceptin treatment ever stopped it due to presumed disease eradication?

In the absence of tests confirming disease advancement, has IT therapy ever been done to prevent disease progression in previously treated HER2 brain mets patients?

What are the worst side effects seen with IT Herceptin? Have patients had to stop being treated due to issues?

[Rolepaul]

Good questions, here are some answers:

Has anyone who has had IT Herceptin
treatment ever stopped it due to presumed disease eradication?
Not sure on this point. Nina was told they would not stop because they do not know if there is any way to determine if there is full remission or not. Insurance continues to pay for it because they also do not know when to stop either.

In the absence of tests confirming disease advancement, has IT therapy ever been done to prevent disease progression in previously treated HER2 brain mets patients?
Nina had Band radiation, Gamma Knife, and Tykerb/Xeloda before IT.

What are the worst side effects seen with IT Herceptin? Have
patients had to stop being treated due to issues?
There is a risk of stroke if the does is too high at the start and some have had headaches. Nine has not had any issues.

[marvass]

Does anyone know if more than 150mg of IT herceptin per week was ever used, since my doctor wants to know, since carol's brain mets are not gone with 150mg IT per 10/11 days.

[marvass]

Yesterday we did the first IT herceptin at 200mg. All went well, no side effects.

[agness]

Hi,

Just saw your question. I'm glad to hear 200 mg was well-tolerated. The only other high dosage I heard of was in the IT Herceptin trial that is ongoing. The dosage I heard of was 80 mg twice a week, which is somewhat comparable to 200 mg in a week.

-A

[YoungMD]

In the NYC Metro area, I know for a fact that Dr. Joachim Baehring at the Yale Smilow Cancer Hospital in New Haven, CT treats leptomeningeal disease with an IT Herceptin regimen. 50 mg or 100 mg IT Herceptin is administered with 50 mg theradopa (cytotoxic agent) on a weekly basis through an Ommaya or lumbar resorvoir. There are minimal side effects at the 100 mg dosage, as in lethargy the day after administration, that's it. I've seen it have brilliant effects.

That being said, I still think radiotherapy is necessary in known areas of disease in the brain and spine. If it was not done already, though, you may want to discuss doing the IT Herceptin first if the tumors are not compromising critical brain stem areas (e.g. controlling breathing) or are causing paralysis.

IT Herceptin has proven to be excellent in prolonging the life of LM patients. I've read case reports of patients pulling 2-4 years until the disease stopped responding. That is the greatest danger with IT Herceptin. Once the tumor mutates to lose the HER2 ligand, the options are limited just to cytotoxic therapies and radiotherapy. IT Methothrexate is allegedly well tolerated (I have no personal experience to attest to that) but controls disease progression for maybe 4-6 months.

So, combination therapies could be a good option. I am personally in favor of IT Herceptin 100 mg every week as a base therapy coupled with the pulsile Tykerb treatment which was made reference to on this forum (protocol of biweekly lapatinib administered orally with a loading dose of 5000 mg /20 pills/ on Day 1, 6250 mg on Day 4 /25 pills/ and 7500 mg on Day 8 /30 pills/ administered every four days therafter). That way, you have two HER2 immunotherapies attacking the tumor.

For those willing to also integrate some additional therapies, CBD oil 2 ml twice a day should be given, Curcumin extract, Rei-Shi mushroom extract, and essential element supplementation as necessary based on bloodwork (especially K, Mg, and Ca if you are using Tykerb in combination with IT Herceptin). Care should also be taken to enrich your diet with tumeric, ginger, garlic, sweet potatoes, habaniero peppers, and eliminate any and all dairy products and oils, plant or animal based.

[dchips1]

Hi What is theradopa? can not find this drug. What is CBD oil ?

Iam living in arizona they say IT methotrexate is very hard on the body. Use is for Valley fever.

Peace and prayers Darita

[YoungMD]

I apologize, the cytotoxic compliment to IT Herceptin used in Yale is IT thiotepa, 50 mg weekly. It is similar to other combination therapies I've read about in the literature, specifically a combination of IT Herceptin and IT methothrexate (100 mg/wk and 25 mg/wk, respectively). The reservation, of course, with a cytotoxic compliment is that it is cytotoxic. Both methothrexate and thiotepa stay around in the meninges and in the body for a long time, and have documented side effects such as arachnoiditis and some neurodegeneration. That being said, they were valuable compliments to IT Herceptin. Using methothrexate or thiotepa in monotherapy stops working after 5-6 months, in some cases longer, simply because you are attacking the tumor with just one agent, rather than a targeted agent and a cytotoxic agent. Other cytotoxic agents that I've encountered in literature was etoposide 1 mg/wk, topotecan, as was mentioned earlier in this thread, and Xeloda as a systemic compliment that has some CNS penetration.

CBD oil is cannabidol oil (hemp oil). While I am cautious about people making outlandish claims that it is a panacea for neoplasms of all kind, real research suggests that brain and breast origin tumors have endocannabinoid receptors that could be targets for at least few of the many cannabidols found in hemp oil. Plus, anecdotal and formal evidence suggests it potentiates response to pain meds, potentially allowing patients to take less pain meds with the same effect. Generally, these compounds also have an anti-inflammatory effect. If it doesn't have THC, it is not psychoactive and in my book, doesn't hurt. The dosage I've seen is 25 mg/day, which in some blends translates to 2 ml of oil a day.

[YoungMD]

I wanted to add also this. In LM patients, CSF flow abnormalities are common. Circulating cancer cells/emboli obstruct the drainage of the meninges and hydrocephalus can develop, with all of its associated clinical manifestations. Although as the CSF clears of cytologically perceptible tumor cells, one would expect that the hydrocephalus subsides or normalizes. During this time, then, extraction of CSF via the Ommaya reservoir should be undertaken, as much as 35 ml per IT administration, until there is MRI confirmed resolution of the hydrocephalus.

If possible, a CSF flow obstruction study should be conducted to make sure that the neuroaxis is accessible to IT administered agents. If there is a tumor blocking CSF flow, say in the lumbar spine, the area below will develop multiple metastasis since it is not being treated, unless systemic therapy is penetrating the BBB in the obstructed area. Such a study, radionuclide ventriculography, also helps to identify gross masses requiring radiotherapy. IT Herceptin or any other cytotoxic agent has limited effect on gross masses, and spot radiation should be applied to the known tumors.

Finally, salvage therapy. What happens when methothrexate stops working? Or Herceptin? Thiotepa is seen as a salvage therapy for when methotrexate fails, but can also be used as a first line therapy, as is done in Yale. In the case of Herceptin, that is more frightening since it may suggest that the tumor underwent clonal selection to lose its HER2 ligand. Tykerb was suggested as a second line salvage therapy in cases of suspected desensitization to Herceptin, combined with Xeloda - the issue, however, being that you need high doses of Tykerb to push a therapeutic dosage into the brain from the bloodstream. I've read a case report in which etoposide 1 mg/wk was used as salvage therapy in the case of methothrexate failure. From what I read in this thread, some MO's may also seek to up the dosage of IT Herceptin to 150 mg or 200 mg/wk, suggesting that the tumor in such cases has simply been downregulated and did not in fact lose the HER2 ligand. A combination of IT Herceptin and Perjeta is also something I think would improve outcomes in the case of IT Herceptin monotherapy failure, but that is just my opinion. For the sake of my Mother, I want to see who would do such a protocol of treatment. Are there others? I've seen IT interferon as a third line therapy in an article, but that is its own can of worms and has probably only limited effect.

[Freakzilla]

Sorry to jump on the thread. Does anyone know if IT Herceptin reaches the Dura layer?

[marvass]

Carol is still with mets
7 months ago she was locally irradiated for 3 mets measuring 12,12, and 7 mm. She continued doing IT herceptin at 250mg every 10 or 11 days till today.

In the first 3 months the mets shrunk to 6,7, and 3 mm. But an MRI last week showed that these have grown up to 13,13 and 8mm.

So today is the last IT herceptin that she is doing. We will start 1250mg/day tykerb and 130mg taxol per week as from today. She can still walk with some help, steroids are at 1mg/day, and still taking IV herceptin at 6mg/kilo.

We will do 6 weeks like this and then do another MRI.

[Ramsay_Bolton]

Hi Mario,

Is Carol able to have Gamma Knife for the lesions? Are they deep brain or leptomengenial?

[marvass]

They are deep brain, but she cannot do a gamma knife

[StephN]

Hello Mario,

Sorry to learn of the growth you described. Maybe slapping those mets with something new will send them slinking away.
I hope her quality of life is well enough after all this time of treatment.

I would like to know what side effects (if any) you could attribute to the IT Herceptin.

All the very best to you both.

[marvass]

intrathecal herceptin had no side effects even at a dose of 250mg. we did this over 100 times in the past 4.5 years

[marvass]

MRI of 2 weeks ago show that the three tumors have shrunk to half, showing that taxol and lapatinib is working. However she is having complications with blood parameters and is in hospital to be controlled, having had very low blood presure 50/20, very high heart beat, 150 while sleeping, rapid breathing, low spo2 needed oxygen, low red bc, low white bc, low platelets, chest infection, near kidney failure, large fluctatuations in potassium, calcium, sodium and chlorides.
However she is settling and is now taking a blood transfusion.

[Mtngrl]

So sorry Carol is so ill. That must be really hard for you both.

Sending warm wishes and hopeful thoughts.

Amy

[Ramsay_Bolton]

Hi Mario, I'm pleased the treatment is working and also hope Carol feels better soon.

Has Carol always been clear of systemic disease? Are you able to try Kadcyla?

[MaineRottweilers]

Prayers that Carol is able to leave the hospital soon. I am so glad that the treatment is working well otherwise.

[Ramsay_Bolton]

What doses of IT Herceptin has everyone been receiving?

[marvass]

Carol passed away yesterday at 2pm gmt+1. Blood pressure fell till spo2 dropped and heart failed. She had an aspiration pneumonia that she could not cope with, mainly because of the taxol, causing complications with blood.

[Mtngrl]

Oh, no. I'm so sorry. You have my deepest condolences.

Thank you for letting us know.

Amy

[TiffanyS]

I’m sorry to hear about Carol. My condolences to you and your family.

[Ramsay_Bolton]

Really sorry to hear this Mario, Carol was an inspiration for a lot of people. This thread has helped save peoples lives.

[StephN]

Marv,
You and Carol fought for each other in such a way as to give so many others hope and a new way to hang on in spite of such negative news.

You have my sincere admiration and prayers that you pain might ease.

[Pamelamary]

So sorry to hear this - condolences to all Carol's family and friends.... Pam

[Rolepaul]

Mario,
I am very sorry to hear this. Carol was an inspiration to everyone that had CNS involvement. My thoughts are with you in this difficult time.
Paul

[marvass]

Thanks everyone for your very kind posts.
I do not know what advances there was on this kind of cancer except that ONT-380 now called tucatinib is moving quickly in trials, and is very promising. Guess it will be the best medicine available soon.

Wish you all good luck.

Mario

[Rolepaul]

Marvin,
I can't imagine how you feel. Nina has done quite well. We are approaching the sixth year of her being on IT Herceptin and Topotecan. November 2 was the 8th anniversary of the discovery of the large lesion on her brain surface. Just under 70 women have contacted me for help with HER+ Brain mets. The survival and no progression rate remains very high. I am sorry Carol wsa not one of those.

[marvass]

Thanks paul. You and Nina were always a great inspiration for us. I will always remain in this thread to help if i can. And Paul is the best in here on this.

Regards
Mario

[KathyT]

I am going to be starting Intrathecal Herceptin hopefully this week. I had the Ommaya Reservoir put on August 1st. Diagnosed June 24th with leptomeningeal Mets.
Has anyone received this treatment or had the Ommaya ??

[Laurel]

Kathy,

I have no experience, but want to wish you a great outcome and amazing response. Please let us all know how you are doing. Hopefully others will chime in soon!

[StephN]

KathyT, you are rounding another bend in a long road. Sorry you have to take that path, but there is a lot of helpful info in this long thread. You may want to ask about a two-pronged approach. There are some advances according to my med onc, but I don't have details, as she was in a hurry!

Will be very interested in how you do in drowning those spots with a great drug.