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Washouts tough for trials!
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Washouts tough for trials!

› Forums › Cutaneous Melanoma Community › Washouts tough for trials!

  • Post
    • March 14, 2014 at 5:29 am
    odonoghue80
    Participant
      Hi, I wanted to ask a few questions for those who are waiting for clinical trials, or this who have waited, or had the "washout" before starting clinical trials. 
      I am currently waiting to start for the Anti-PD1 & Anti-KIR trial. I started washing out on Feb 28. The planning set date to start trial is April 1 this year. I was feeling pretty good starting earlier this month but now I'm noticing more tumors and much more growth. Not only that, I'm starting to feel weak, bad appetite, and can't do much (swelling from a groin tumor in right leg). I can feel new subcutaneous tumors daily and have feel about 5 small spots on my scalp as well.
      I still have to pass my brain MRI next Monday which makes me very nervous. While I'm in this washout and, not being on medication, I'm just allowing the melanoma to grow fast! I'm not certain if this is the best method for me. I'm not bed bound and can still walk, etc, but again, the growth is visible. 
      I was also on BRAF inhibitor for the last 14 months so I'm wondering if this is making the growth happening faster?
      Just curious if others are struggling with this same issue?
      To be honest, I thought I was going to be feeling better while off the medication, eating well, etc. But its been the actual opposite.
      Thanks,
      Shane
    Viewing 5 reply threads
    • Replies
        • March 14, 2014 at 12:21 pm
        POW
        Participant

          Shane, I am so sorry to learn about your struggle. This is such a tough decision to make!

          Zelboraf worked well for my brother for 4 or 5 months and then one of his lung tumors started growing again. His oncologist said that he was becoming resistant to Zelboraf and should consider switching to a clinical trial. Unfortunately, he was one of those who did not make it through the 30-day washout period following Zelboraf. During his pre-trial MRI they found several new brain mets and he was disqualified from the trial. 

          I think that the best thing you can do is what you are doing– have a Plan B in mind if you decide to opt out of the trial. The good news is that BMS just agreed to offer Nivolumab on an Expanded Access Program. It will probably take 2 or 3 months for that program to be up and running. In the meanwhile, perhaps you could try Tafinlar + Mekinist to quickly shrink the tumors while waiting for the EAP to start. BMS has already submitted Nivolumab to the FDA and approval may be possible by the end of the year. That could be an option for you, too.

          I hope that you are able to hold out for the clinical trial– that is still quite possible. However, after getting the results of the MRI and consulting with your oncologist, you may decide that the timing for this clinical trial is not right for you now. The objective is to keep fighting day-by-day, month-by-month year-by-year until you find a treatment that really knocks your melanoma on its ass. Yes, it is exhausting hand-to-hand combat, but it is worth it!

           

           

          • March 14, 2014 at 12:21 pm
          POW
          Participant

            Shane, I am so sorry to learn about your struggle. This is such a tough decision to make!

            Zelboraf worked well for my brother for 4 or 5 months and then one of his lung tumors started growing again. His oncologist said that he was becoming resistant to Zelboraf and should consider switching to a clinical trial. Unfortunately, he was one of those who did not make it through the 30-day washout period following Zelboraf. During his pre-trial MRI they found several new brain mets and he was disqualified from the trial. 

            I think that the best thing you can do is what you are doing– have a Plan B in mind if you decide to opt out of the trial. The good news is that BMS just agreed to offer Nivolumab on an Expanded Access Program. It will probably take 2 or 3 months for that program to be up and running. In the meanwhile, perhaps you could try Tafinlar + Mekinist to quickly shrink the tumors while waiting for the EAP to start. BMS has already submitted Nivolumab to the FDA and approval may be possible by the end of the year. That could be an option for you, too.

            I hope that you are able to hold out for the clinical trial– that is still quite possible. However, after getting the results of the MRI and consulting with your oncologist, you may decide that the timing for this clinical trial is not right for you now. The objective is to keep fighting day-by-day, month-by-month year-by-year until you find a treatment that really knocks your melanoma on its ass. Yes, it is exhausting hand-to-hand combat, but it is worth it!

             

             

              • March 14, 2014 at 12:32 pm
              G-Samsa
              Participant

                Thought the EAP was for the MERCK product (MK3475)?

                • March 14, 2014 at 9:22 pm
                POW
                Participant

                  Sorry. Yes, you are correct. It was Merck that just announded an Expanded Access Program for their version of anti-PD1 (MK3475). Interestingly, I just saw a position vacancy announcement for BMS posted in December. BMS was looking for a new Director of Expanded Access for nivolumab!! I guess that will be coming soon!!

                  • March 14, 2014 at 9:24 pm
                  POW
                  Participant

                    Just for fun, here's the link to the postion description: http://www.linkedin.com/jobs2/view/10028634

                    • March 14, 2014 at 9:24 pm
                    POW
                    Participant

                      Just for fun, here's the link to the postion description: http://www.linkedin.com/jobs2/view/10028634

                      • March 14, 2014 at 9:24 pm
                      POW
                      Participant

                        Just for fun, here's the link to the postion description: http://www.linkedin.com/jobs2/view/10028634

                        • March 14, 2014 at 9:22 pm
                        POW
                        Participant

                          Sorry. Yes, you are correct. It was Merck that just announded an Expanded Access Program for their version of anti-PD1 (MK3475). Interestingly, I just saw a position vacancy announcement for BMS posted in December. BMS was looking for a new Director of Expanded Access for nivolumab!! I guess that will be coming soon!!

                          • March 14, 2014 at 9:22 pm
                          POW
                          Participant

                            Sorry. Yes, you are correct. It was Merck that just announded an Expanded Access Program for their version of anti-PD1 (MK3475). Interestingly, I just saw a position vacancy announcement for BMS posted in December. BMS was looking for a new Director of Expanded Access for nivolumab!! I guess that will be coming soon!!

                            • March 14, 2014 at 12:32 pm
                            G-Samsa
                            Participant

                              Thought the EAP was for the MERCK product (MK3475)?

                              • March 14, 2014 at 12:32 pm
                              G-Samsa
                              Participant

                                Thought the EAP was for the MERCK product (MK3475)?

                              • March 14, 2014 at 12:21 pm
                              POW
                              Participant

                                Shane, I am so sorry to learn about your struggle. This is such a tough decision to make!

                                Zelboraf worked well for my brother for 4 or 5 months and then one of his lung tumors started growing again. His oncologist said that he was becoming resistant to Zelboraf and should consider switching to a clinical trial. Unfortunately, he was one of those who did not make it through the 30-day washout period following Zelboraf. During his pre-trial MRI they found several new brain mets and he was disqualified from the trial. 

                                I think that the best thing you can do is what you are doing– have a Plan B in mind if you decide to opt out of the trial. The good news is that BMS just agreed to offer Nivolumab on an Expanded Access Program. It will probably take 2 or 3 months for that program to be up and running. In the meanwhile, perhaps you could try Tafinlar + Mekinist to quickly shrink the tumors while waiting for the EAP to start. BMS has already submitted Nivolumab to the FDA and approval may be possible by the end of the year. That could be an option for you, too.

                                I hope that you are able to hold out for the clinical trial– that is still quite possible. However, after getting the results of the MRI and consulting with your oncologist, you may decide that the timing for this clinical trial is not right for you now. The objective is to keep fighting day-by-day, month-by-month year-by-year until you find a treatment that really knocks your melanoma on its ass. Yes, it is exhausting hand-to-hand combat, but it is worth it!

                                 

                                 

                                • March 15, 2014 at 2:29 am
                                Bubbles
                                Participant

                                  Hey Shane,

                                  Sorry for what you are dealing with and the misinformation that derailed your question.  Those 28 days before starting a trial are pretty crazy no matter who you are and having to watch things grow is worse yet!!  I have no great words of wisdom except that there are others here who have dealt with similar things and made it and I am betting on you!!! Hang in there and I will be sending you my very best thoughts for all things good on Monday!!!  You can always take another tact if need be, but I've heard good things about the anti-PD1/anti-KIR trial and I am hoping you make it!!!

                                  Hang in there!!! Yours, Celeste

                                  • March 15, 2014 at 2:29 am
                                  Bubbles
                                  Participant

                                    Hey Shane,

                                    Sorry for what you are dealing with and the misinformation that derailed your question.  Those 28 days before starting a trial are pretty crazy no matter who you are and having to watch things grow is worse yet!!  I have no great words of wisdom except that there are others here who have dealt with similar things and made it and I am betting on you!!! Hang in there and I will be sending you my very best thoughts for all things good on Monday!!!  You can always take another tact if need be, but I've heard good things about the anti-PD1/anti-KIR trial and I am hoping you make it!!!

                                    Hang in there!!! Yours, Celeste

                                      • March 15, 2014 at 5:34 am
                                      odonoghue80
                                      Participant

                                        Thank You Celeste! I'm just honestly nervous that I'll even make it that far. So we'll see what happens.

                                        • March 15, 2014 at 5:34 am
                                        odonoghue80
                                        Participant

                                          Thank You Celeste! I'm just honestly nervous that I'll even make it that far. So we'll see what happens.

                                          • March 15, 2014 at 5:34 am
                                          odonoghue80
                                          Participant

                                            Thank You Celeste! I'm just honestly nervous that I'll even make it that far. So we'll see what happens.

                                          • March 15, 2014 at 2:29 am
                                          Bubbles
                                          Participant

                                            Hey Shane,

                                            Sorry for what you are dealing with and the misinformation that derailed your question.  Those 28 days before starting a trial are pretty crazy no matter who you are and having to watch things grow is worse yet!!  I have no great words of wisdom except that there are others here who have dealt with similar things and made it and I am betting on you!!! Hang in there and I will be sending you my very best thoughts for all things good on Monday!!!  You can always take another tact if need be, but I've heard good things about the anti-PD1/anti-KIR trial and I am hoping you make it!!!

                                            Hang in there!!! Yours, Celeste

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