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

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/N...tuzumab&rank=1

http://clinicaltrials.gov/ct2/show?t...tuzumab&rank=2

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

Are there any more doing it?


Mario

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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+m etastasis#post269040

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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.

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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.

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

Fingers crossed

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

thanks for your post.

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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.

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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?

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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).

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Karen

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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.

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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!!

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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!!

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

Yay! Sending warm love your way!
Karen

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

Thanks Karen
God bless you.

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

Mario,

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

Paul

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

What facility are you at in Chicago?
Karen

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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.

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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.

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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.

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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.

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

Thanks Paul

Mario

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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

Re: Intrathecal (IT) Herceptin (Trastuzumab) for brain mets (Leptomeningeal Metastase
 

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