FOR ALL ON CLINICAL TRIALS (edited name)

[skypup]

Dianne, Sky and I are crossing all crossable body parts and sending prayers aloft for you. I just hated to read the news from your latest post. You are one of the pioneers, and while I'm glad you got such a long time off chemo I am definitely not happy that you may have to switch back to conventional treatments. Dang that CRC! I was just reading how promising the pd-1 and pd-l1 results have been for lung cancer. Nothing has really been successful for us yet.

I'll be looking for your update soon, and wishing you good things!
Xoxo

[Novamomof2]

Amy (aka Ranger)- I will definitely let the ladies of know your hello.

Diane, all the best with your doc visits this week.

[ranger]

thanks!

[dianne052506]

Squeaked past again!!!!
The study allows for a 50% increase from baseline when the dimensions of each marker tumor are multipled, then totalled. With last week's scan, I am up to 43%. Some of the nodules that were too small to be counted in the study in August 2012 have increased, but they are not part of the baseline so can't count in the measured increase. I also just realized that one of the marker nodules is a mediastinal node that has not changed over the past 7 years. Probably benign, but it's lack of chage factored into the lower total, so I'm not complaining. Plus, 18 months off chemo and there are still new nodules being reported.
I'm still in shock. I was expecting to be on chemo by Christmas; now, I'm staying on the study, at least through the scan at the end of the year.
Thank you for all the prayers and good wishes. They have truly made a difference in my life.
Dianne

[dianne052506]

Connectivity problems. Double post.

[vickitwo]

Yahoo! Wonderful news! Hope you have a great holiday season!

[Maia]

Yahoooooooooooooooooooooooooooooooo, Dianne!!!
Ok, I'm happy for you, you can tell
Enjoy : )

[skypup]

So, so glad you are staying on the study! And glad the growth is slow--sometimes that is the best answer to our prayers. have you heard how other CRC patients are doing on the study?

Gosh, it just sunk in. Stage IV and 18 months without chemo. Wonderful!

[dianne052506]

Skypup,
I was so floored, I forgot to ask. I know there is one lady, age 70+, who was on the single agent trial and got a complete response so that her liver tumors disappeared. Her son is a doctor and he was worried that she wouldn't tolerate oxaliplatin well, so he sent her to Dr. P. for the trial before she had any chemo. I'll email him this evening and ask about others.
As I said, I'm still in shock. I'm sure I forgot to tell Dr. P., "thank you." It can't be an easy business to be in, but I'm glad he's there.
Dianne

[gep]

very happy for you, Dianne. Keep us posted!
Gloria

[Maia]

(Posted this as a separated thread, posting it here too)

A NEW clinical trial with Roche-Genentech's anti-PD-L1 agent (MPDL3280A or RG7446) has just started. It will test MPDL3280A in combination with other new agent -Cobimetinib, which is a MEK inhibitor. Anti-PD-L1 agent is administered IV, cobimetinib is oral, given by mouth.

A Study of the Safety and Pharmacology of MPDL3280A Given With Cobimetinib in Patients With Locally Advanced or Metastatic Cancer
http://clinicaltrials.gov/ct2/show/study/NCT01988896

The study is interventional, not randomized -all participants receive the drugs. There are 2 phases planned: dose finding and dose expansion.
There are many locations --this time, outside the States too: Canada (yes! : ), Germany, Australia, UK, Spain, etc. Right now (Feb 1st) they seem to be recruiting only in New York (I guess, Sloan), Tennessee and North Caroline.

Drugs that target the PD-1 and PD-L1 'pathway', in cancer biology, are not chemotherapy but immunotherapies; these agents have been the stars at ASCO and ESCO 2013. MPDL3280A is the agent that looks more promising for CRC.
If this this board, we have been talking about this topic very often ( viewtopic.php?f=1&t=42504 viewtopic.php?f=1&t=42504#p314278 viewtopic.php?f=1&t=39022 )
Our good friend Dianne has been in a trial with MPDL3280A plus Avastin since August 2012 and generously has been sharing her experience, here and there (viewtopic.php?f=1&t=38822&p=310705#p310705 viewtopic.php?f=1&t=38822&start=360#p320385 viewtopic.php?f=1&t=45437&p=329217#p329206 )

I'm keeping on eye on it and will be updating when new locations change from "Not yet recruiting" to "Recruiting"

The older, up-going trials with MPDL3280A, relevant for CRC, are the one in combination with Avastin and/or chemo (http://clinicaltrials.gov/ct2/show/NCT01633970 ) and the one as single agent (http://www.clinicaltrials.gov/ct2/show/NCT01375842 )

[skypup]

Thank you Maia!!!!!

[WifeOfMike]

Update: Nivolumab & Ipilimumab CLINICAL TRIAL...........

A Study of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Colon Cancer (CheckMate 142)
http://clinicaltrials.gov/show/NCT02060188
http://www.cancer.gov/clinicaltrials/se ... ofessional

We just got back from Los Angeles (our 3rd attempt at finding quality care). I think we hit pay dirt...... Although THE clinical trial we were hoping to sign up for MAY not be available because a genetic testing we had done showed hubby is Microsatellite Stable (test MAY be asking for HIGH status), they gave us FOUR optional clinical trials to consider BASED UPON HIS EXACT genetic Inaccuracies. WE ARE VERY HAPPY to NOT be looking at 8000+ clinical trials and trying to make factual based GUESSES as to which one COULD be viable!!

Our new Cancer Wizard (Who is in charge of Clinical Trials at that particular Cancer Research Institute) is clarifying this. Nivolumab & Ipilimumab CLINICAL TRIAL IN Los Angeles is NOT yet recruiting, and I had National Cancer Institutes PDQ version as well as National Health Institute's version of the trial printouts in hand at meeting. I am now reading details of those other four trials, and awaiting test results of CT scan of clinical trial he is presently on (due Thursday).......... to decipher hubbies next chess move in this game called CANCER. It is also VERY apparent genetic testing is going to be a HUGE factor in the eligibility of clinical trials now and in the immediate future, as it has with some of the FDA approved standard care drugs (IE: WILD KRAS, BRAF & NRAS status in Erbitux)!!!!

Being prepared like a Girl Scout, comes in handy
I HIGHLY recommend that basic genetic profiling be done on who ever has colon cancer and is considering clinical trials. It helped us tremendously knowing hubbies status ahead of game time. Some of these trials have very limited openings, particularly ones such as these two drugs that have had a lot of publicity in both the clinical and general populace media...... and a waiting line to get in. In our case it immediately gave the DR other viable clinical trials that would address hubby's issues head on.

Wife of Mike,
Vicki

[WifeOfMike]

Forgive me if I'm re-posting here as well as Re: News on the 'other' anti PD-1: Nivolumab. Immunotherapy, as I feel this is an important trial to let everyone know status on.

Update on status of Hubby entering into Los Angeles Ipilimumab and Nivolumab combo clinical trial
As noted, we were told in LA that hubby might be excluded for his Microsatellite status (he is MSI-S or stable), they also told us that they were not yet recruiting. We were ahead of the recruitment status and had made an appointment anyway to perhaps gain a waiting place in line. Like camping out in front of stores at Christmas

I sent several emails off to San Francisco (who is now listed as recruiting) and asked for clarification as to whether indeed MSI status would be a factor. Here is there answer:
"The arm for patients with MSI stable is currently on hold at this time. I will know by the end of June when it will be open. I'm currently out of the office so I will check for a status update upon my return on 6/23. I'm sorry for the inconvenience."

I had been told by another person running a clinical trial that they sometimes pause trials while they compile data, or an event making them take pause & a hard look occurs. I'm hoping it is the first, or perhaps they are just getting the teams in place and totally informed prior to starting the trial in a new clinic, or a new "arm" (segment). I will let everyone know when I find the answer.

I did look thru these postings and noticed Busymommaof3 may also be trying out for this same clinical trial. Hopefully she does too and we can both give updates to pave the path for anyone behind us or at least share notes of how each is holding up/ side effects/ or Woo-Hoo moments. I also LOVE to hear is Anyone is in consideration or enrolled currently!

We are also waiting for Cat Scan to let us know hubby's status of the small trial he is currently in. It is the two month trial status update to check against baseline tests prior to starting the trial. I am praying he does well, but am looking forward as usual to determine the next move. There is always a mandatory wash out period (2-3 weeks to allow any previous treatments to clear out of his system, before a new one gets introduced). I also have to take into consideration the other 4 trials that ARE currently available in LA, that are geared towards his HIGH expressions in CMET and VEGFR2

As many of you can attest to, ANYTHING to do with Cancer is stressful. For us, it intensified as soon as he finished 3 lines of standard care and we ventured into the "Clinical Trial World". Here you are faced with forks in the road, minimal or unknown responses/ side effects, often times less info available (for even the most avid researchers). I greatly appreciate ANY news I get here from anyone. It is what spurs me on, and keeps HOPE alive under our roof at night. MANY heartfelt THANKS!!!!!

Best Wishes,
Wife of Mike,
Vicki