Caryn starting new trial...Ertumaxomab

[eric]

http://www.mskcc.org/mskcc/html/2270.cfm?IRBNO=07-155
PHASE II STUDY OF THE TRIFUNCTIONAL BISPECIFIC ANTI-HER-2/NEU X ANTI-CD3 ANTIBODY ERTUMAXOMAB IN PATIENTS WITH HER-2/NEU OVEREXPRESSING (3+ OR 2+/FISH+) METASTATIC BREAST CANCER PROGRESSING AFTER TRASTUZUMAB TREATMENT Purpose :
Trastuzumab is an antibody used to treat breast cancer in women whose tumors produce excess amounts of the HER2 protein. HER2 is a protein found on the surface of certain cancer cells and can make the cells divide and grow. In some of these women, however, the cancer stops responding to trastuzumab and continues to grow.

The purpose of this study is to evaluate the safety and effectiveness of ertumaxomab, another type of monoclonal antibody that targets HER2, in women with metastatic breast cancer that no longer responds to trastuzumab. Antibodies are proteins that are part of the immune system and are important in defending the body against foreign substances. By bringing immune cells and cancer cells together, researchers hope to kill more cancer cells this way.

Eligibility : To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have HER2-positive metastatic breast cancer that no longer responds to trastuzumab.
Patients must not be confined to a bed or chair for more than half of their normal waking hours.
Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Shanu Modi (http://www.mskcc.org/prg/prg/bios/906.cfm) at 212-639-5243.

[Joan M]

Eric,

I've been wondering how Caryn has been doing. And also thinking there were other trials that she could participate in. I'm very glad she was able to get into this trial. Please give her my best.

Joan

[Bill]

Eric, I'm so glad that you were able to find this trial and that Caryn qualified. Also, it was very helpful to others here that you posted the study criteria. Please keep up the good work. You know that you and Caryn are in so many thoughts and prayers.

[Yorkiegirl]

I am glad to hear that Caryn qualified for this trail. My thoughts and prayers will be with you both.

[caya]

Eric, I am so happy for Caryn. Please let her know that I am thinking of her and keeping my fingers crossed for a good result.

all the best
caya

[Julie2]

Eric,

I am so happy to hear that Caryn was able to participate in the trial. I am praying that this is a magic bullet for her. Is this the only drug she will be on or will it be in combination with a chemo?

Julie

[SoCalGal]

Eric-
Thanks very much for posting the details. I am curious to know how more...I am always thinking of plan b and also plan c. Wishing you both an easy time. --Flori

[Mary Anne in TX]

Eric, thank you for letting us know about Caryn's new trial. Here's to a smooth "trial" and fabulous results. I'll be anxious to hear more. ma

[eric]

Thank you all. Your wishes and prayers mean a lot.

This is an interesting phase 2 trial as it is a single drug that attaches to her2 as well as the immune system. The phase one included 17 patients where 1 achieved complete remission, 2 achieved partial remission and 2 maintained stable disease. I wasn't crazy about these odds but according to Caryn's Onc they're outstanding for a phase one trial. 60 people will particpate in 15-20 centers in the US.

The schedule is also interesting...
* Week one: screening
* Week two: 1st infusion (3 hr infusion and 6 hours observation)
* Week three: 2nd infusion (3 hr infusion and 6 hours observation)
* Week four: 3rd infusion (3 hr infusion and 6 hours observation)
* Week five: follow up
* One month later: follow up
* One month later: follow up
* Two months later: follow up
* Two months later: follow up and if response is seen return in one month to confirm response.

I'll keep everyone informed.

Eric

[Barbara2]

Praying this new drug will be the one that knocks out all cancer cells for her. Each day we get a bit closer...

[Colleens_Husband]

Eric:

The odds aren't wonderful, but we will pray that Caryn will be the one with complete remission. It is good that she is in the trial. Eric, please know that you and Caryn will be in our thoughts and prayers.

Lee

[Faith in Him]

Eric,

Praying for you and your wife that the drugs work and that the s/e are easy to handle.

Tonya

[lilyecuadorian]

Eric and Carin , my best wishes for this trial I always like new trial, I think they have new good thing that the oldones drugs are missing ..so let hope that this new trial ...get them all those bad cell on Carin body ...my felling is that it will ...and with (Eric )best caregiver and a good research news is a plus for a great husband descriptions Lol , I'm glad that you get on this trial it look like it is easy to manage...

[eric]

Thank you!
Eric

[harrie]

Eric,...wow, sounds very encouraging!! Wishing her good results!
Maryanne

[Barbara H.]

Hi Eric,
I am wishing Caryn all the best with this new trial. Keep us posted.
Barbara H.

[Mary Jo]

Dear Eric and Caryn...I'm thankful this trial was available for Caryn and I pray that it is effective for her. Also, praying for God's Peace to surround you both as you continue on the journey.

Love to you....

Mary Jo

[fullofbeans]

Eric,

My best wishes to both of you. I am glad that you have found a good trial. Sending good thoughts your way, your love and dedication to Caryn is commendable.

[Jackie07]

'Ditto' from Texas.

[chrisy]

Eric, this sounds like a very interesting trial - I like the idea of working with your immune system. I hope Caryn does well (and feels better) on this this trial. She's lucky to have such a committed partner to do this research. You're the best.

[Jean]

Eric,
this is good news that Caryn qualified for the trial.
I am praying the odds will be in your favor....out of 17
one had complete remission...that is great news...
2 stable, 2 partial...hey that is impressive.

Think strong and positive.

Best Regards,
Jean

[eric]

Thanks all!
To keep you updated, Caryn had her first infusion last week and happily only had a headache the day of the infusion and the day after. She was happy it wasn't anything more.
On a less positive note her liver functions were slightly elevated so her treatment is postponed until next week. I'll keep you informed since the drug goes from 10mg to 100mg.

Love and Light (in memory of Lisa),
Eric

[eric]

Unfortunately, Caryn's not going to be able to continue on this trial after only one infusion. She missed last weeks infusion since her liver functions were elevated and this week 2 of her functions are slightly high. Considering that the 1st infusion is only one tenth the dosage that she would recieve on the 2nd and 3rd infusion, I can't imagine what her functions would have been after that. Our thought is to take a break from trials and go back to something more traditional for now. We're both very disappointed and scared as she's running through a bunch quickly. All we need though, is to hit the right drug to buy us a good amount of time until some better options are available. Thanks for all your positive wishes and I'll let you know what the next step in the plan is, as soon as I know.

[caya]

Eric,

I am sorry to hear that Caryn cannot continue on the trial. Hopefully her liver functions will stabilize and the next treatment will work for her. Please let her know that from one Caryn to another, I am thinking of her.

all the best
caya

[Joan M]

Eric,

Sorry to hear the news about Caryn. Her liver probably needs a rest from the trials as you mentioned. Please let her know that she's in my thoughts and prayers.

Joan