Clinical Trials and the Outcome!

KJones1969

I would like to get some feed on any clinical trials and the outcome of them. My husband is on Afinitor 7.5 mg right now and he is doing okay with it. I just want to make sure we are fighting this with the best possible treatment out there and wondering about clinical trials. They have had a few at Duke but none he qualifies for. Any input or advice you all can give me is greatly appreciated.

pjune127

Sarah Cannon Research Institute
I am participating in a clinical trial of PD1 in Nashville, Tennessee, right near Vanderbilt. So far, so good. You can read my thread about MPDL3280A. Here is the link to the trial. I was told there are 2 slots open for qualified patients. I have been on the trial for 7 weeks and have already shown a response. The next scan (in January) will tell the tale. Good luck!

http://clinicaltrials.gov/ct2/show/NCT01633970

Happy to talk further if you like.

Paula

alice124

Trial History
K-

As I believe you're familiar, John started the Votrient/Nivolumab trial in May. His history is noted below. He won't have another scan until February 2013.

In the meantime, we've learned the Votrient/Nivolumab arm of the trial is not being continued due to liver toxicity in most patients. But those patients not experiencing serious liver toxicity or other serious side effects will remain in the trial as long as reduction/stabilization is occurring.

John has experienced some elevation in liver enzymes but not serious enough to pull him off the trial. He had bloodwork today and his ALT (alanine aminotransferase) continues to climb from 52 on 11/14/12 to 62 today. The "62" isn't high enough to pull him off the trial, however. I think only a dozen or so patients remain in this arm of the trial.

For the first time today, John's blood pressure was a little high 148/88, and his nurse has instructed him to keep an eye on it (taking twice a day). His pressure has been low for the past year. But prior to his kidney removal he did take medication for bp.

John’s Trial History:

Background: 10/14/11 – Diagnosed with Kidney cancer clear cell/grade 4/stage 4 – with sarcomatoid features and lung mets; also has soft tissue mass in shoulder area and pelvic area.

5/10/2012 – Began MDX1106/Votrient trial BMS 936558 (Also receives Xgeva infusions)
RESPONSES at 6 week intervals:
6/20/2012 – CT scan showed 31% reduction in tumor burden;
8/1/2012 – CT scan showed additional 11% tumor reduction for total of 42%:
9/12/2012 – CT scan showed additional 4% tumor burden for a total of 46%;
10/24/2012 - CT scan showed 1% reduction for a total of 47%.

NEXT SCAN (now on 12 week scan schedule) will be February 2013.

foxhd

alice124 said:

Trial History
K-

As I believe you're familiar, John started the Votrient/Nivolumab trial in May. His history is noted below. He won't have another scan until February 2013.

In the meantime, we've learned the Votrient/Nivolumab arm of the trial is not being continued due to liver toxicity in most patients. But those patients not experiencing serious liver toxicity or other serious side effects will remain in the trial as long as reduction/stabilization is occurring.

John has experienced some elevation in liver enzymes but not serious enough to pull him off the trial. He had bloodwork today and his ALT (alanine aminotransferase) continues to climb from 52 on 11/14/12 to 62 today. The "62" isn't high enough to pull him off the trial, however. I think only a dozen or so patients remain in this arm of the trial.

For the first time today, John's blood pressure was a little high 148/88, and his nurse has instructed him to keep an eye on it (taking twice a day). His pressure has been low for the past year. But prior to his kidney removal he did take medication for bp.

John’s Trial History:

Background: 10/14/11 – Diagnosed with Kidney cancer clear cell/grade 4/stage 4 – with sarcomatoid features and lung mets; also has soft tissue mass in shoulder area and pelvic area.

5/10/2012 – Began MDX1106/Votrient trial BMS 936558 (Also receives Xgeva infusions)
RESPONSES at 6 week intervals:
6/20/2012 – CT scan showed 31% reduction in tumor burden;
8/1/2012 – CT scan showed additional 11% tumor reduction for total of 42%:
9/12/2012 – CT scan showed additional 4% tumor burden for a total of 46%;
10/24/2012 - CT scan showed 1% reduction for a total of 47%.

NEXT SCAN (now on 12 week scan schedule) will be February 2013.

trials
Kjones, It would be shorter for you to review my posts for the past year re: MDX-1106 and the fact that I will be posting for at least another year. That pretty much says alot.

KJones1969

foxhd said:

trials
Kjones, It would be shorter for you to review my posts for the past year re: MDX-1106 and the fact that I will be posting for at least another year. That pretty much says alot.

Thanks for responding
Thank you all for responding. Alice I hope the Votrient trial continues to help John. Fox I have read a lot of your information on MDX-1106 and you have been very successful. With my hubs being on Afinitor now his doctor said this is the second line of treatment and trials are limited for him. We have found one at another facility and not Duke that he would possibly qualify for, we will find out next week at his appointment at Duke if his doctor thinks it would be a good fit for him. I just want to make sure he has the best oppotunity at fighting cancer and that Afinitor is the best thing for him at the time. The study they are looking at is LBH589 in combination with Sorafenib. By chance have any of you heard any information on that? Thanks and I'll keep you all in my thoughts and prayers.