Trial Trastuzumab-MCC-DM1 (I think it's working)

[Barbara H.]

Hi Everyone,
I just wanted to give an update of the trial I am on. I just received my second infusion last Thursday. I had been off all treatment since the end of May because you have to be off treatment for four weeks to qualify. Unfortunately, as a result of no treatment, my bone mets had really started to grow and become painful. By August it became very difficult for me to sleep. In fact, one night the week before I started the trial, I only had two hours of sleep before getting up and going to school. This was all due to pain. No pain relievers would help and prescription pain relievers make me nauseous. In reality, I had been off chemo other than Herceptin since November when I had to have brain surgery due to necrosis. I really felt as if I was in bad shape and was desperate to begin this trial

My first infusion took all day. The needed blood work, consultations, and the infusion took 1 and 1/2 hours. Then I needed to be observed for four hours with constant temperature and blood pressure monitoring. After a final blood test I could leave, but had to return on Friday, Saturday, and Sunday for additional blood tests. This is a problem for me because I have bad veins and the trial protocol will not allow blood tests from my port.

During my first infusion my nose started running and I felt quite achy. Unfortunately, that night I had to give a speech and meet will my parents at Curriculum Night. It was difficult, but I did it. The next day I felt pretty awful, but went to school. By that evening I had a fever of 101F. At first I thought is was a reaction to the new drug, but now I think I caught a virus from my students. Three were out that week with colds and fevers, and by the beginning of the past week two of the other third grade teachers had it. I probably will never know for sure.

This past Thursday I had my second infusion and it was quite uneventful. The following day I was tired, but went to see "Wicked" that night with no problem.

Here is the good news. By the second night after the first infusion I was able to sleep with virtually no pain. After being in pain for two months, this feels like a true miracle to me. My hip is still sore during the day and I favor it somewhat, but I feel that this treatment is quickly making a huge difference. It is also very easy to tolerate. Therefore, if you are looking for a treatment option, I would definitely investigate this trial. I also wonder if there is anyone else on this website how is taking this drug.

I will continue to give updates, and will know more after I have my scans later this month.

I give my best to everyone. I have read everyone's posts, but just haven't had time to respond. The beginning of the school year is always very hectic.

Best regards,
Barbara H.

[SandyR]

Barbara, I am also a teacher (first/second grade), so I was very inspired to hear your struggle with your pain and work. I am keeping you in my thoughts and wish the best for your trial. It sounds as though great things are happening in the trials! I also like to hear the steps that the trials entail. You give the rest of us much hope! Thank you for your post!
-SandyR

[Lolly]

Barbara, thank you for posting your experience so far with the trial. It's so encouraging to hear you had such an immediate response! Please keep us posted, and thanks for participating in the trial. Hoping this drug will advance and become avaliable, as it really sounds promising. I checked into the trial but have had too many chemo regimens to qualify, but maybe will be able to have it down the road.

<3 Lolly

[jones7676]

Barbara, how are the treatments going? I am glad to hear you are sleeping better. Please keep us updated on how it is going.

Another Barb!

[Julie2]

Barbara,

How is the treatment going? Have you had a scan recently? Thinking of you.

Julie

[kareneg]

Hi Barbara,

I am praying that you are doing well also, when you can let us know how you are. Your in my thoughts and prayers.

[Barbara H.]

I just had scans yesterday. I am doing much better and am currently free of pain. I really believe that this is a miracle drug. It also has minimal side effects. Unfortunately, this drug elevates liver enzyme levels in some people. Mine were too high last week to be treated. Hopefully, all will be well next week. I will let you know more when I receive the results of my scans.
Barbara H.

[lilyecuadorian]

thanks Barbara for all the updated ...I'm fallow all your post ..searching about how are you doing ...you know sister is so important to me............. take care youyr self and I have a question how we can make the liver enzime get low (but naturally ) ???

[Barbara H.]

Elevated liver enzymes are a side effect of this drug in many people. I am also on a very high dosage. My doctor told me not to use Tylenol or alcohol. Other than that, there is not much I can do. He does not want me taking supplements to lower them. Whenever they go too high, I just need to skip my treatment for that week. Hopefully, that will do the trick.
Barbara H.

[kareneg]

I hope skipping one treatment gets those liver enzimes in check! You are in my prayers and I am so glad there is no more pain!

[lexigirl]

Barbara,

I am praying for good news on your scans. I am happy to read that your pain is less.

Hugs,
Lexi

[MPB]

Hi Ladies I am new here, I have been a bc warrior since 1996. I will be starting this same trail that Barbara is on hoping for the same quick response. I have 6 tumors on my neck.

Marsha

[Patrice]

Barbara, you and Lily are in my thoughts and prayers. Please let us know how you're doing.

Patrice (also from Newton)

[Barbara H.]

Wow, Patrice. We should connect. I am doing well. My bone scan showed progression, but no new lesions and my oncologist said it can light up from healing. My cat scan showed improvement with a few lymph nodes that had enlarged due to the bone mets, and my MRI is fine. Everything else is NED. The good news is that the CEA went from 17 to 7. This marker is the best indicator for me. It was out of control because I was off treatment for so long.

I feel this is a great trial and I hope more members will have the opportunity to try it. It is easy to tolerate and I am able to continue my teaching.

Best regards and Happy Thanksgiving to those who celebrate.

Barbara H.

[eric]

Barbara,

That's great news!! Thanks for sharing. As a reminder, did you have any success with herceptin or tykerb prior to this trial?

Eric

[lexigirl]

Barbara,

Such good news! I am happy that you are feeling well enough to teach. I wish you continued success.

Hugs,
Lexi

[Barbara H.]

Hi Eric,
I was never on Tykerb. Herceptin alone worked for me for 1 1/2 years. When I started on it I had a 3 cm brain met, skin mets, and lung, and liver mets, but no bone mets. It wiped everything out, but bone mets appeared. I then went on Navelbine, but started to progress at this time last year. I then had a biopsy, but it didn't show if my ER/PR markers had changed. I then waited for this trial and am now in it. As I stated before, it is very easy to tolerate. Herceptin has kept my other mets at bay.
Best wishes,
Barbara H.

[eric]

Looking forward to continued great news for and from you.

[Julie2]

Barbara,

Great news, wish you continued success on this trial.

Julie

[Patrice]

Barbara,

Reading your post this evening before Thanksgiving has given me one more thing to be grateful for. I'll private email you after the holidays to see if you would like to get together! I'd love it.

Warm regards, Patrice

[runtolive]

Barb.. any updates... how many doses have u received.. what dose are u getting..

[Barbara H.]

Hi Everyone,
I had a bone and cat scan last week and saw my oncologist today. My cat scan looks good and my bone scan indicates that the bones are healing. My tumor markers are great indicators for me and are now both normal. My CEA is now 1.7. I am hoping that it will eventually be under one. This is a great trial and I highly recommend it . It has minimal side effects, and I can live a normal life and continue working. I am on the phase 1 weekly trial.
Best wishes,
Barbara H.

[tousled1]

Barbara,

Such great news and couldn't come at a better time of year. Congratulations. Praying for you that the trial continues to give you great results.

[eric]

Barbara - FANTASTIC!!!! What great news. A CEA of 1.7 indicates that you are well within the normal range. What a great way for you to celebrate the new year. This appears to be a very exciting new drug and you and Lily are wonderful trailblazers.

Eric

[runtolive]

this is great news barb... how do they do the weekly dose.
the phase 2 trial dose is 3.6 mg/m2 .. what is the weekly dose you are on...

run to live

[lilyecuadorian]

Dear Barbara ...you was one of the main reason to get me on this trail ...when I ask my Doc about trials he mentioned about this and in a second I remember your post ...and get exited ...and ask for it ...after all the test I think I did a great choose because my ct scan are great , my Doc said ...and thanks to you ..I really hope so that another Lady's on this site get in to ..like us ...plus my thoughts was genentech need all her costumer back (because is for patient who herceptin fail) so that way they still doing so a great sales in the future ....congratulalion you ct scan give me more hope ...like mine also give hope for somebody else ...

[hermiracles]

Dear Barbara and Lily - so glad this trial seems to be working so well for both of you! ((Big Hugs)) Wonderful!
Blessings
Hermiracles

[Patrice]

Barbara, what great news & wonderful way to start the New Year. You'll continue to be in my thoughts and prayers.

Warm regards, Patrice

[kareneg]

Dear Barbara,

What wonderful news I am so happy for you. Have a wonderful holiday. You are always in my thoughts and prayers. Please keep us posted on how you are doing.

[runtolive]

marsha.. have not seen you post in awhile.. hope all is well.. how is your treatment going..

[StephN]

Dear Barbara and Lily -
I am a little slow to get over to this part of the forum, but you have both been in my most POSITIVE thoughts and GOOD wishes.

So great to hear good news from you both at a time when we really need it! We know Barbara was a good responder to Herceptin so it was with every bit of faith that you would do will in this new trial.

KEEP on responding, ladies. Maybe with results like these they can fast-track this drug, and more oncs could use it off-label for those not in a trial area.

[MPB]

Hi Ladies,

Just wanted to update you. My scans looked great the neck nodes have skriked in to half the size they where. No new ones! Liver is stable, just a little progession in the hips and spine. Not surprised I am sore more often. So I am going into 08 rip roaring to go!!!
God has truly blessed me so many times through this joruney. I am so humbled and grateful for all his love and my friends! Also all of you have been so full of Grace for me. Thank you and have a peace filled new year!

[Lolly]

Barbara, Lily and Marsha,
Great news on your scan results!!! As Marsha above says, go into '08 rip roaring!

<3 Lolly

[Barbara H.]

Hi MPB,
You may just be sore. In the beginning the bone scans can show progression even when the cancer is not progressing. You will probably need to wait for a few more scans before you can determine what is going on. I have been on the trial since September and the CT and bone scan is finally showing response to treatment.

This is what my most recent CT scan on 12/20 indicated:
"Metastatic involvement of the bones is apparent, with areas of increasing sclerosis in comparison to prior study, possibly a treatment effect."

My bone scan indicated: There has been a slight decrease in the intensity of the radiotracer uptake associated with lesions in the right clavicle and the right hemipelvis. The additional lesions, including the one in the T11 and L1 vertebral bodies appear unchanged.

While this does not sound great, my tumor markers are now normal, and they are an excellent benchmark for me. I have the sense that it takes a while for these scans to show measurable response in the bones.

Best wishes,
Barbara H.

[runtolive]

marsha.. how was your first treatment..

runtolive

[runtolive]

barb.. how has your treatment been going.. long time no hear...

runtolive

[Barbara H.]

Everything is going well. I had a CT scan and bone scan today. There is really no news and nothing to post until I receive the results of these tests.
Thanks for thinking of me.
Barbara

[Joy]

the good news!

[runtolive]

hopefully the drug wipes out all the pain in your bones... like you say .. feels like its working. stay strong..

[Mykentuckyhome]

I am very much interested in this trial. Can anyone tell me about it? What are the requirements ? I had taken hercepton for over 2 yrs. till I had progression. Please anyone? Are these trials at certain places? Thanks linda

[Barbara H.]

Go to Lily's site. There is a post that gives information about the trial. I am on phase 1, but there are more places that are offering the phase 2 trial.
Good luck,
Barbara

[runtolive]

linda.. call asap.. dont let it progress one more day..

http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00509769

they are running the every 3 week trial in louisville..

Kentuckiana Cancer Institute
4500 churchman rd
Louisville Kentucky 40202 United States
Kentuckiana Cancer Institute (http://anywho.yellowpages.com/info-LMS65196537/Kentuckiana-Cancer-Institute)

Map (http://anywho.yellowpages.com/info-LMS65196537/Kentuckiana-Cancer-Institute/maps)

(502) 368-0345

[runtolive]

wrong zip.. 40215
run to live

[runtolive]

better link

United States, KentuckyKentuckiana Cancer Institute Recruiting Louisville, Kentucky, United States, 40202 Contact: Leslie Haysley 502-561-8200 lhaysley@kci.us (lhaysley%40kci.us?subject=NCT00509769, TDM4258g, A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer)

http://www.clinicaltrials.gov/ct2/show/NCT00509769?term=dm1&rank=4&show_locs=Y#locn

[runtolive]

barb,lily, marsha..

http://www.oncology-times.com/pt/pt-core/template-journal/oncotimes/media/Carlson-CFS-Trastuzumab-OT-Jan102008.pdf

article by dr burris .. just scroll down.. about tras-dm1..

[Mykentuckyhome]

Thanks run to live, I appreciate the info and article and plan to talk about this with my onc. As part of the requirement it says no more than 3 different chemos. Does that mean 3 different chemo regimens ? The first regimen I had was taxotere and gemzar,and herceptin together. Does that count as 1 0r 2? thanks mykentuckyhome

[Barbara H.]

You will have to speak with your oncologist about the chemo. I am not sure.
Barbara

[runtolive]

that is one regimen.. but make the call.. dont delay.. dont give the cancer even one extra day inside your body...

[Barbara H.]

I received the results of my bone scan and CT scans. The scans indicated that the cancer in my bones is stable. Apparently, it takes a long time to get better results and even bones that have healed can be seen on these scans.
I feel well and feel pleased with these results.
Barbara H.

[lilyecuadorian]

I'm glad for this news ...the same results for me ...stable is good news ( Kareng said, my Doctor said ,nurses said) so is good news ....

[runtolive]

http://www.aapspharmaceutica.com/meetings/files/121/jumbenelsontranslationalchromopharmacology.pdf

[Mykentuckyhome]

I am seriously thinking of going on this trial. I got all the papers from louisville and Im going to talk to my onc on tues. I know that barb , marsha and lily are on this study, so the questions are directed to them. How long did it take between signing all the papers and your initial dose? I know there is a washout time of 2 weeks where you cant be on anything, and what kind of side effects have any of you had? They said I would be the first to go on this in kentucky so its kind of scary. Any input would be greatly appreciated.

[runtolive]

ky home.. read some on my past postings and those of barb, lilly and marsha.... this trial is a godsend for her2 patients.. 3-4 yrs from now this drug will the the standard of care in breast cancer patients with her2 type cancer.

[runtolive]

http://www.cancernetwork.com/showArticle.jhtml?articleID=180200338

a snippet

When the Herceptin antibody binds to a tumor cell expressing HER-2, the Herceptin/DM1 complex is internalized. The intracellular environment favors freeing of the DM1 from the antibody, makes the DM1 active, and kills the cell," Dr. Schwall said.
Three Breast Cancer Models
The conjugate was tested in three models. The first was a line of MCF7-HER2 human breast cancer cells engineered to express high levels of HER-2 and transplanted into nude mice. The conjugate caused complete tumor regression in all mice treated, while trastuzumab alone only slowed tumor growth. This experiment was repeated several times, with 9 to 10 mice per group. "With the conjugate, all of the tumors just disappeared," Dr. Schwall said.
The second model was nude mice transplanted with MDA-MB-361 breast tumor cells, which naturally express high levels of HER-2. As in the first experiment, the conjugate induced complete tumor regression in all 10 mice treated, while unconjugated trastuzumab only slowed tumor growth.
The third model was mammary tumors from MMTV-HER-2 transgenic mice transplanted into the mammary fat pads of 10 nontransgenic nude mice. The transplanted tumors grew aggressively and were allowed to reach 100 mm³ before treatment was initiated. "For reasons we don’t understand, Herceptin is not very effective against these tumors, even though they express high levels of HER-2," Dr. Schwall said.
When the mice were treated with the trastuzumab/DM1 conjugate, tumors regressed by more than 90% in all mice within 20 days. This effect was seen only in tumors overexpressing HER-2. "The tumors shrink and stay small for 60 to 70 days then start to grow back. When we treated them again, they responded again at similar levels," he said.
Maximal efficacy in this model was seen at a DM1 dose of 300 µg/kg, which corresponds to about 18 mg/kg of the conjugate, given once a week for 5 consecutive weeks. "These results show that Herceptin/DM1 has better activity than Herceptin alone in both Herceptin-responsive and Herceptin-resistant breast tumor models," Dr. Schwall said.

[chrisy]

Well dang!!!!!

That's some pretty impressive stuff. I am so wanting to get into this trial, still waiting for it to open at UCSF tho.

[runtolive]

and i have great olives..

[chrisy]

the runts are always the best and most loveable, runt olive, and you are proof of the rule~

I got news today that the UCSF docs have been sent to Genentech, so it's just a matter of people taking care of business to get the trial underway there. I expect to be spending Monday enrolling and starting in the trial! Hoping this will be even better than flowers and chocolate...

[runtolive]

good luck.. lets us all know when you begin..

[ELLE]

I Maybe Entered Into The Trial With Trastuzumab-mcc-dm1- How Have You Done On This Trial? Anything I Should Know Before Deciding To Enter The Trial? I Had Bc Start In 1998 With Tumor On Right Breast-mastectomy And Reconst.stage 1 No Lymph Node Involvement--mets To Bone Since 2001 And Spot On Liver As Of 2007-just Now Using Faslodex And Herceptin Since End Of December 2007 And It Is Working So Far- My Onc Is Considering Placing Me On This Trial When The Faslodex Stops Working- Scans Scheduled For Next Week-if They Show Anything Has Worsened I Will Go Into The Trial Now. Ers

[runtolive]

elle.. dont wait for the faslodex to stop working.. ask your oncologist to start now. prevention in your case IS THE CURE... which trial .. the weekly phase 1 or the every 3 week phase 2 trial.. i heard from a friend that the phase 1 trial will likely convert to phase 2 each week dosing possibly this summer.

regarding side effects.. pretty much the same as herceptin alone.. i have never been on it.. but i know many girls here on the forum are using it with great success..

we are still waiting for chrisy to update us on her treatment.... i think she has had her 2nd dose on the 3 week trial..

run to live.

[runtolive]

hey barb.. how you been...

[Mykentuckyhome]

Yesterday was my first infusion. I left with heartburn and chills but after sleeping half the day today im up and moving. I chalk that up to how many tubes of blood they took, at least ten by the time I finished. Then I had to go back to the hospital in town last night for yet another blood draw.I will keep you all posted. Almost back to normal.

[MPB]

Glad to hear your feeling better. I am on round 7 next week. I still get the chills on the first night. I had my scans yesterday so we will see if we are still NED for the 2nd time.

MPB

[runtolive]

good luck marsha.. we are praying for you... clean scans and blue skies..

run to live

[Barbara H.]

I received the results of my CT scan today. My bone mets remain stable and my tumor markers are normal. I continue to do well and feel good. This is a great drug and all the patients at the Dana Farber are doing well on it. It is certainly a great option to try.
Best wishes,
Barbara H.