tkirzhner
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Posts:18
Hi
I was offered to join this trial at MSKCC. The trial brochure says this was not tried on
people before. Although I am excited I also worry about
it's safety. Would like to hear from people who know better or have first
hand experience with MEDI 4736.
Forums
Reply # - January 20, 2015, 05:12 AM
Hi,
Hi,
As of now there are many people who have used this drug though it is still under investigation. Phase I clinical trials are the first trials in humans called the drug escalation phase where they start low and over time raise the amount of drug in a person to find the dose a person can handle. I can only imagine that it's very scary to be the first people and I thank them every day.
We have a ton of patient info on the drug. It's doing very well. Here is the list of threads from people who know better and have first hand experience with MEDI 4736. http://cancergrace.org/search-results?q=MEDI%204736
Thanks to all who participate in trials and who make new treatment options possible.
Janine
Reply # - January 20, 2015, 05:18 AM
This is one of the trials I
This is one of the trials I tried to get into. It has shown very good results! I was rejected because my biopsy came back "inconclusive" twice for the PDL-1. Good luck and let us know how you do!
Reply # - January 20, 2015, 09:31 AM
Janine,
Janine,
Thank you for the encouraging words and helpful link
I will try not to be a chicken :)
Karen ,
You may want to check into the offered MEDI4736 trials again.
The trial I am looking at does not require PDL1 positive reading
Although 18 months ago my biopsy showed PDL1 positive my doctor decided not
to get me involved with the trial because I started getting symptoms ( bone pain).
He prescribed chemo right away.
Now when the time came for the trial. clinic nurse told me that no PDL1 testing
is not required for the arm I am assigned to. From what I understood they are reviewing several
solid tumors, not only lung cancer.
I will keep you posted.
Reply # - January 20, 2015, 12:11 PM
I tried for for the MEI4736
I tried for for the MEI4736 in November and another trial in December. After my 2nd lung biopsy (each trial wanted their own) it was discovered that there is no gene mutation either. Most trials need that in order to know how to treat. Where is this trial being offered?
Karen
Reply # - January 20, 2015, 08:29 PM
Karen,
Karen,
It is offerred to me at Memorial Sloan but there are about 46 location around the world
Try Phase 1/2 study to evaluate MEDI4736.
I am still in the process of researching this trial and not fully understanding why they
do not require PDL1.
I will let you know when I know more.
Reply # - January 21, 2015, 04:21 AM
Karen,
Karen,
If you search for MEDI4736 trials on clinicaltrials.gov, at the bottom of each trial description there will be a list of the trial locations. You can also try searching for a particular location (for example, you could search for MEDI4746 AND Chicago).
JimC
Forum moderator
Reply # - January 21, 2015, 06:54 AM
The trial I got rejected for
The trial I got rejected for was A phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736. This is offered at Moffitt Cancer Center in Tampa, FL and has been for quite some time. This is the closest (4 hours away) for me.My informed consent and research authorization form does NOT mention PDL-1 at all. I was told of this after my 1st lung biopsy. I was then given the opportunity to try for another trial which was Tremelimumab in combination with MEDI4736. I was told that I would not be rejected from this one for any reason. I questioned this twice as I had to have another lung biopsy (the last one was only 4 weeks away), another brain MRI and another CAT scan. I agreed, waited the 2 weeks for them to schedule me to begin treatment and was told (Christmas Eve) that no genetic mutations were found on my samples and therefore I am rejected again. Imagine how upset I was....I felt that I had been misled and lied to.
I am telling you all this (even though it is on my new person introduction) so that you don't get wrapped around these trials as I did. Dr. West had to kick me in the butt (telling it like it is) which made me turn and start proven treatment right away. This is not to say I won't look into trials again one day, but definitely not for awhile.
Karen
Reply # - January 21, 2015, 06:38 PM
Karen,
Karen,
Interesting information! During my initial interview they told me that I do not have to be
PDL1 positive so I concluded that the trial is warranted for me.
I am not wrapped around this at all. In fact I was doing well on my Alimta/ Avastin
maintenance until I got cellulitis. Was not a big deal for me but my doc
took me off this drug. The second opinion doctor said he would continue
same treatment.
After 2 months without treatment the ct scan showed minor progression and
my doctor sent me for immunotherapy. I thought "what the heck...everyone is
so excited about it - let me try".
Now I am getting really nervous in the unknown territory.
Reply # - January 21, 2015, 06:49 PM
Don't be nervous, be excited!
Don't be nervous, be excited!!! I have heard really terrific outcomes from this drug and was very disappointed with being rejected and the way I was treated. What is holding you up? Have you done all the test they require? The waiting period was the worse for me because there was zero communication from my trial center. I could not even guess when to book hotel reservations and this all took place during the Oct-Dec holidays.
I am excited for you and can't wait to hear how great you are doing. Keep updating and I was always respond!
Karen
Reply # - January 22, 2015, 09:22 AM
Karen,
Karen,
Thank you for encouragement. I am just starting tests today:
CT, MRI, blood, EKG. Do not know yet when is biopsy scheduled.
I am lucky in the way I am in NYC and being treated at MSKCC so no need
to travel far.
As for terrific outcome of the immunotherapy I am being realistic. I hear more people
have failed than succeeded on it. So you have to be really lucky.
And those who have success also suffer some autoimmune and heart issues. Just as Dr Weiss
mentioned , it is better to go with what is known as long as it helps and then jump to the trial.
Maybe in a near future it will improve enough to help us all.
Meanwhile I am cautiously optimistic.
I will keep you posted on my progress.
Tamara
Reply # - January 22, 2015, 10:01 AM
Tamara,
Tamara,
Have you checked out other forums for people who have been on MEDI4736?
Reply # - January 22, 2015, 12:53 PM
I checked on Inspire and here
I checked on Inspire and here at GRACE. Would appreciate if you point out to other forums.
Update on my testing:
just talked to radiologist for biopsy. He mentioned that I may
have not big enough new tumors to obtain tissue for PDL1.
I remembered your story and asked him whether I need it to be accepted.
He called my trial doctor and she confirmed that I will get the drug regardless.
We'll see.
Reply # - January 22, 2015, 05:10 PM
That is what I was told with
That is what I was told with the 2nd trial I went for....until they told me no genetic mutations were found. Ask if they need that before you go through the lung biopsy. BTW, my tumors came out clear and too small for testing PDL-1 as well. That is why they kept saying "inconclusive".
I visit LUNGevity and PatientsLikeME forums. The LUNGevity has links to people who are on clinical trials and their experiences. Hope this helps as I always learn something new every time I visit all these forums.
Reply # - January 22, 2015, 08:38 PM
Karen,
Karen,
Thanks for pointing out to another forums. I will definitely visit.
Here is an inclusion criteria for this trial. It does not mention tequirement of PDL-1 marker.
"In the dose-expansion phase: histologically- or cytologically- confirmed advanced solid tumor where if an approved first-line therapy is available, subjects must have failed, be intolerant to, be ineligible for, or have refused treatment.
Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
Adequate organ and marrow function.
Subjects must have at least 1 measurable lesion.
Available archived tumor tissue sample.
Willingness to provide consent for biopsy samples (dose-expansion only)"
So I'll see if this will work out for me.
I did ask the trial coordinator again and she said I would
get the drug regardless.
Reply # - January 23, 2015, 10:04 AM
Yup, my consent form said
Yup, my consent form said those exact words. I am glad you will get a chance at this and I guess it wasn't meant to be for me. Hope your biopsy is soon so the wait won't be too much longer.
Keep your mind and body busy while waiting!!!