FOR ALL ON CLINICAL TRIALS (edited name)

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dianne052506
Posts: 1651
Joined: Sun Nov 02, 2008 11:57 pm
Location: North Carolina

Re: Clinical Trial - PROGRESS REPORT

Postby dianne052506 » Sun Jan 06, 2013 8:01 pm

Gloria, Niki,

Yes, I am on the trial that has two arms - either MPDL3280A + Avastin, or MPDL3280A + Folfox + Avastin. This is totally separate from the single-agent trial, although Dr. P. is involved in both and it was my understanding from him that the single-agent trial wanted to enroll more CRC patients. I'll check on this with him Monday.
I'll also ask about the trial I am on and its availability, but, as far as I know, they are still recruiting patients. I am allergic to oxaliplatin now, so I was forced onto the arm with just the study drug and Avastin.
Dianne
May 06 Stage IV CC: liver,ovarian mets
Oct 07 inoperable lung mets
Feb 08 - Apr'12 chemo
allergic to oxaliplatin, irinotecan
Aug '12-Feb'14 Genentech PD-L1/Avastin trial
Mar '14 -radiation to largest lung nodule
still recovering; looking at trials again

crazymotherof8
Posts: 392
Joined: Wed Jun 29, 2011 3:30 pm
Location: SE Arizona

Re: Clinical Trial - PROGRESS REPORT

Postby crazymotherof8 » Mon Jan 07, 2013 1:44 am

Thank you so much Diane!! The closest center with the Avastin or Avastin + chemo trial is in Colorado. I was planning on calling them in the am but look forward to hearing what your Dr. P says!
Niki
DH Matt - 49 - father to 8
Dx Mar11 w/Mets to liver, lungs Folfox + Avastin Mar 11 - Jul 11
Sept11 Spleen remvd bc low platelets
Oct12 Folfox+Avastin
Mar12 Folfiri+Avastin
Aug12 bone mets; irinotecan+Erbitux
Dec12 chemo failed - trial
passed June 17, 2013

gep
Posts: 418
Joined: Wed Aug 19, 2009 6:21 pm
Location: Chicago, IL

Re: Clinical Trial - PROGRESS REPORT

Postby gep » Mon Jan 07, 2013 9:16 am

We were told that the arm with avastin in NC is not open right now but that they are expecting more openings this month. Waiting to hear.
Gloria
caregiver to Eli
dx 8/07 3B
7/09 - liver & celiac lym node
1/10 Liver Res & Lym nodes out
7/10 Back - Liver & other lym nodes
12/12 hit chemo wall
1/12 Clin Trial - MEK & AKT inhibitors
3/12 Trial failed/ spheres 4/12
7/30/13 Eli died.

dianne052506
Posts: 1651
Joined: Sun Nov 02, 2008 11:57 pm
Location: North Carolina

Re: Clinical Trial - PROGRESS REPORT

Postby dianne052506 » Mon Jan 07, 2013 9:45 am

I spoke this morning with the trial coordinator at Carolinas BioOncology. This is my best understanding of her explanation:

On both studies - the single-agent and the drug combination that I am on - the FDA requires that patients be enrolled in groups, referred to as "cohorts." When a cohort if full, then there is a waiting period to examine the toxicity on those patients before additional slots can be added. At this time, for the single-agent studies, the CRC slots on the current cohort are full. The study dose toxicity period will end within the next 2 weeks, then more slots open up. This lady suggests calling back to the location, asking to be put on a waiting list for the next cohort, then calling back w/in 2 weeks to check the progress. Overall, this study will only be enrolling patients for a few more months.

For the single-agent study, the patient must must be positive for the B7H1 protein - either by testing w/ current biopsy or by testing of stored tumor material.

For the combination study, the protein testing is not currently required. Again, the cohorts fill and open back up. CBO and others should be adding more patients to this study for a while, since it is about a full year behind the single-agent study.

Hope this helps. If anybody does make it to CBO, please let me know and I will meet you there!
Dianne
May 06 Stage IV CC: liver,ovarian mets
Oct 07 inoperable lung mets
Feb 08 - Apr'12 chemo
allergic to oxaliplatin, irinotecan
Aug '12-Feb'14 Genentech PD-L1/Avastin trial
Mar '14 -radiation to largest lung nodule
still recovering; looking at trials again

crazymotherof8
Posts: 392
Joined: Wed Jun 29, 2011 3:30 pm
Location: SE Arizona

Re: Clinical Trial - PROGRESS REPORT

Postby crazymotherof8 » Mon Jan 07, 2013 10:00 am

Thank you Diane!!! I will call on both trials and get hubby on waiting list.
Niki
DH Matt - 49 - father to 8
Dx Mar11 w/Mets to liver, lungs Folfox + Avastin Mar 11 - Jul 11
Sept11 Spleen remvd bc low platelets
Oct12 Folfox+Avastin
Mar12 Folfiri+Avastin
Aug12 bone mets; irinotecan+Erbitux
Dec12 chemo failed - trial
passed June 17, 2013

crazymotherof8
Posts: 392
Joined: Wed Jun 29, 2011 3:30 pm
Location: SE Arizona

Re: Clinical Trial - PROGRESS REPORT

Postby crazymotherof8 » Mon Jan 07, 2013 10:24 am

Just spoke with AZ again about the single agent trial and the latest information she has from last week is that they will not be adding any more CC cohort groups; this would be at all of the single agent sites. I told her I would be calling again over the next few weeks to check and see if anything has changed.
I am calling CO right now about the Avastin trial. I will let you all know shortly what they say.
Niki
DH Matt - 49 - father to 8
Dx Mar11 w/Mets to liver, lungs Folfox + Avastin Mar 11 - Jul 11
Sept11 Spleen remvd bc low platelets
Oct12 Folfox+Avastin
Mar12 Folfiri+Avastin
Aug12 bone mets; irinotecan+Erbitux
Dec12 chemo failed - trial
passed June 17, 2013

crazymotherof8
Posts: 392
Joined: Wed Jun 29, 2011 3:30 pm
Location: SE Arizona

Re: Clinical Trial - PROGRESS REPORT

Postby crazymotherof8 » Mon Jan 07, 2013 12:56 pm

I just got a call back from University of Denver about the trial with PD-1 with Avastin and with Folfox + Avastin. This is what he told me.
The arm with PD-1 + Avastin is closed completely as they have filled the study and have collected the data. He doesn't know when this will be taken to Phase II but said that there were NO side effects from this drug and that it did show some benefit to cancer patients so he expects that it will go to phase II. The trial with Avastin + PD-1 and Folfox is still open but Matt would have to have been off of Folfox for a year. The year point for him is in March. We are looking into other trials and will come back to this one in a couple of months if we don't find something else in the meantime.

Dianne,
When you are in contact with the dr there in NC again will you ask them about what I was told both in AZ as well as CO?

Gloria,
In NC did they tell you that the Avastin + PD-1 arm will be opening up in a couple of weeks or the one with Folfox + Avastin + PD-1?

Thanks to all!!!!! This is what this site is for.....helping each other find the best care possible.

Niki
DH Matt - 49 - father to 8
Dx Mar11 w/Mets to liver, lungs Folfox + Avastin Mar 11 - Jul 11
Sept11 Spleen remvd bc low platelets
Oct12 Folfox+Avastin
Mar12 Folfiri+Avastin
Aug12 bone mets; irinotecan+Erbitux
Dec12 chemo failed - trial
passed June 17, 2013

dianne052506
Posts: 1651
Joined: Sun Nov 02, 2008 11:57 pm
Location: North Carolina

Re: Clinical Trial - PROGRESS REPORT

Postby dianne052506 » Mon Jan 07, 2013 1:00 pm

I hate this confusion. I trust Dr. P., so I am hoping he is the best informed.
Dianne
May 06 Stage IV CC: liver,ovarian mets
Oct 07 inoperable lung mets
Feb 08 - Apr'12 chemo
allergic to oxaliplatin, irinotecan
Aug '12-Feb'14 Genentech PD-L1/Avastin trial
Mar '14 -radiation to largest lung nodule
still recovering; looking at trials again

crazymotherof8
Posts: 392
Joined: Wed Jun 29, 2011 3:30 pm
Location: SE Arizona

Re: Clinical Trial - PROGRESS REPORT

Postby crazymotherof8 » Mon Jan 07, 2013 8:48 pm

Ok I figured it would not hurt to call CO back and ask more questions and maybe try to figure out why we all are getting conflicting information. This time when I called he said he would call the manager and see if any of Arm A, which is PD-L1 with only Avastin would have any more openings. He found out that they are considering going from 11 to 20 patients on this arm and it he put me on the waiting list. So it looks like NC WAS right after all and I guess you have to push a little to get ALL of the facts!!

Arm 2 is the Avastin + Folfox + PD-L1 and it is wide open as not a lot of CC patients have either not used Folfox or not had it in over a year. (you have to have not had it at all or have not had it in a year) My husband will have been off of Folfox a year in March.

I am going to keep calling the AZ site about the single agent trial as things might change there as well according to NC who seem to know what the heck is going on!! LOL!!!

Thanks for getting me to keep pushing.....................
Niki
DH Matt - 49 - father to 8
Dx Mar11 w/Mets to liver, lungs Folfox + Avastin Mar 11 - Jul 11
Sept11 Spleen remvd bc low platelets
Oct12 Folfox+Avastin
Mar12 Folfiri+Avastin
Aug12 bone mets; irinotecan+Erbitux
Dec12 chemo failed - trial
passed June 17, 2013

gep
Posts: 418
Joined: Wed Aug 19, 2009 6:21 pm
Location: Chicago, IL

Re: Clinical Trial - PROGRESS REPORT

Postby gep » Mon Jan 07, 2013 10:46 pm

Sorry I didn't see this sooner. My husband also called Georgetown who may have Avastin plus PDL-1 slots opening, too, they said. They are all waiting for the drug company to open up the slots. I actually emailed genentech and was told the trial is in NC, Georgetown and I think, Dana Farber? My husband was told by NC that they would open later this month. In the meantime, he met with Dr. Bendell at Sarah Cannon in Nashville. This morning they called and offered him a slot in a trial with a MEK and AKT inhibitor combo (http://www.clinicaltrials.gov/ct2/show/ ... le&rank=16). They advised him to go forward with this and if the PDL-1 study opens he can back out if he prefers that one. He just wants to be on something as he's been off chemo since the end of November.
This is supposed to be a good study, too. Anyone know anything about these drugs?
Gloria
caregiver to Eli
dx 8/07 3B
7/09 - liver & celiac lym node
1/10 Liver Res & Lym nodes out
7/10 Back - Liver & other lym nodes
12/12 hit chemo wall
1/12 Clin Trial - MEK & AKT inhibitors
3/12 Trial failed/ spheres 4/12
7/30/13 Eli died.

dianne052506
Posts: 1651
Joined: Sun Nov 02, 2008 11:57 pm
Location: North Carolina

Re: Clinical Trial - PROGRESS REPORT

Postby dianne052506 » Tue Jan 08, 2013 1:19 am

When I spoke with Dr. Powderly Thursday, he didn't say "If" the drug goes to Phase I and Phase II trials, he said, "When." I can't say that he believes MPDL3280A is THE cure, but he certainly seems to believe it is helpiing enough people that it is a viable product.

I like what the people in CO told Niki - that there were no side effects. It's hard for me to say if I even have any that are related to the study. I'm tired all the time, but, gee, in the last 67 months, I've had 3 abdominal surgeries, 68 round of chemo, and 100 or so rounds of Avastin - and all this was before starting the study! I dream of new patients being offered a therapy for cancer where the side effects aren't also horrendous.

Gloria, congratulations on getting DH accepted into the trial in Tennessee. I don't know anything at all about the study. Have you started another thread asking questions? I also have found out a lot just Googling PD-1 and Genetech. Perhaps you can find out more just with internet searches. I am pleased that the people there are honest enough to say you can back out and chose another trial if you like. Sounds like they have the patients' best interests at heart.

Niki, I hope one of the studies opens up in perfect time for your DH. Since the single-agent study requires the positive protein test, do you know for certain that there is stored tissue available for testing? I don't guess anyone could be talked into doing the testing in advance of the slot opening.

Dianne
May 06 Stage IV CC: liver,ovarian mets
Oct 07 inoperable lung mets
Feb 08 - Apr'12 chemo
allergic to oxaliplatin, irinotecan
Aug '12-Feb'14 Genentech PD-L1/Avastin trial
Mar '14 -radiation to largest lung nodule
still recovering; looking at trials again

gep
Posts: 418
Joined: Wed Aug 19, 2009 6:21 pm
Location: Chicago, IL

Re: Clinical Trial - PROGRESS REPORT

Postby gep » Tue Jan 08, 2013 10:27 am

Dianne and everyone,
I haven't started another thread yet. I will say to everyone on this thread that what I've learned in this process this month is that the trend in treatment is moving toward tumor testing to target pathways. There's a place called Foundation Medicine in Cambridge that is the place that I've heard mentioned twice for doing this independently. Otherwise, you go to a research place and they do it for free as part of the clinical trial process. Not all clinical trials require it but this seems to be a trend. Foundation has been doing their type of tumor testing since last June, I think.
Gloria
caregiver to Eli
dx 8/07 3B
7/09 - liver & celiac lym node
1/10 Liver Res & Lym nodes out
7/10 Back - Liver & other lym nodes
12/12 hit chemo wall
1/12 Clin Trial - MEK & AKT inhibitors
3/12 Trial failed/ spheres 4/12
7/30/13 Eli died.

usopen
Posts: 188
Joined: Mon Jul 18, 2011 12:37 pm

Re: Clinical Trial - PROGRESS REPORT

Postby usopen » Tue Jan 08, 2013 11:57 am

Thank you all for sharing.....Thanks Dianne for all your time.

Gep - thanks for the tumor testing info. I'm interested in the single agent. I have plenty of stored tissue at Sloan, and the first hospital, too, when this all began.
I'm curious if there is much difference in the tumor when there are different surgeries a year apart. I had the original colon tumor surgery, then liver tumor tissue stored a year later. I don't know anything about this. But wonder how much the tumors mutate. And does it matter which tumors they test. I guess I'll be asking that, too. Just thinking to myself really......So much to do.
Wonder how much the tumor testing is when you pay for it yourself. I feel like I need to get it done ahead of time, to spare lost time waiting to actually get into the trial.

Joan

gepguest

Re: Clinical Trial - PROGRESS REPORT

Postby gepguest » Tue Jan 08, 2013 6:43 pm

This is Gloria as guest because I can never remember my log in on my work computer. Anyway, my husband talked to Dr. P this morning. Dr. P said they're waiting for the additional slots to open but none are open now. He told my husband to go forward with the Sarah Cannon trial and then to touch base in a few months as he said he's got other trials apart from the PDL-1 one, too. He was very nice. I just wish he was calling to say that a slot had opened now. Anyway, Eli (my husband) is in Nashville now. Going to have PET, blood, etc. done tomorrow in anticipation of first treatment next week.
Gloria

dianne052506
Posts: 1651
Joined: Sun Nov 02, 2008 11:57 pm
Location: North Carolina

Re: Clinical Trial - PROGRESS REPORT

Postby dianne052506 » Tue Jan 08, 2013 8:55 pm

Gloria,
sorry Dr. P. didn't have anything to offer right now, but I'm glad your husband got a chance to speak with him. I'll let you know if I hear anything on trial availability.
Dianne
May 06 Stage IV CC: liver,ovarian mets
Oct 07 inoperable lung mets
Feb 08 - Apr'12 chemo
allergic to oxaliplatin, irinotecan
Aug '12-Feb'14 Genentech PD-L1/Avastin trial
Mar '14 -radiation to largest lung nodule
still recovering; looking at trials again


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