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Ridiculous trial troubles, part deux

Forums General Melanoma Community Ridiculous trial troubles, part deux

  • Post
    shellebrownies
    Participant

      Well, Don went in this week for a CT scan and brain MRI after having his 4th chemo treatment. I had been concerned since after the 3rd round when his LDH numbers started creeping up instead of coming down. Unsurprisingly, the scans showed some regrowth. (They also found a small blood clot in his lung, so now we add blood thinners to the ever-expanding list of medications he takes…)

      Well, Don went in this week for a CT scan and brain MRI after having his 4th chemo treatment. I had been concerned since after the 3rd round when his LDH numbers started creeping up instead of coming down. Unsurprisingly, the scans showed some regrowth. (They also found a small blood clot in his lung, so now we add blood thinners to the ever-expanding list of medications he takes…)

      Our plan B was the Compassionate Use Zelboraf trial. So we go in yesterday for his EKG and derm appointment for the trial. While we were there, Dr. Lawrence comes in to see us. He said that they got the test results back from the tissue sample…and that Roche is saying that Don is NOT BRAF positive!

      This was the SAME sample that was used in May when we were trying to get in to the GSK BRAF/MEK trial…the same one that came up BRAF positive on their test!

      Now this gets complicated. The doctor said they are appealing to Roche to try and get Don accepted to the trial based on the other BRAF test. However, now that the drug has been FDA approved and the FDA requires that the drug can only be prescribed after a positive result with a FDA approved test (as in only Roche's test), I'm not sure if that's going to happen.

      There has been talk about perhaps taking another tissue sample if their appeal is denied. But, what happens if that comes back negative?

      Sigh. Wish I knew. We meet with Dr. Lawrence on Monday; maybe we'll have better news then.

       

      Michelle, wife of Don

    Viewing 11 reply threads
    • Replies
        LynnLuc
        Participant

          Well if it comes back neg  then he shouldn't do the trial…it can make everything much worse if he doesn't have the mutation.

          LynnLuc
          Participant

            Well if it comes back neg  then he shouldn't do the trial…it can make everything much worse if he doesn't have the mutation.

            LynnLuc
            Participant

              Well if it comes back neg  then he shouldn't do the trial…it can make everything much worse if he doesn't have the mutation.

              LynnLuc
              Participant

                Well if it comes back neg  then he shouldn't do the trial…it can make everything much worse if he doesn't have the mutation.

                LynnLuc
                Participant

                  Well if it comes back neg  then he shouldn't do the trial…it can make everything much worse if he doesn't have the mutation.

                  LynnLuc
                  Participant

                    Well if it comes back neg  then he shouldn't do the trial…it can make everything much worse if he doesn't have the mutation.

                    James from Sydney
                    Participant

                      maybe try one of the other Trials that combine BRAF and MEK. I think it compares the Combo vs BRAF alone so Don would get BRAF either way. Sorry not sure of the name of the Trial.

                      best wishes

                      James

                      James from Sydney
                      Participant

                        maybe try one of the other Trials that combine BRAF and MEK. I think it compares the Combo vs BRAF alone so Don would get BRAF either way. Sorry not sure of the name of the Trial.

                        best wishes

                        James

                        Phil S
                        Participant
                          Michelle. I am so sorry to hear that your plan B isn’t working out right now. That’s so crazy on the BRAF testing, maybe he is braf positive just not the V600?? kind they are looking for with the approved drug. I don’t know much about braf, but I am sure Dr Lawrence will have suggestions. If braf drugs are out, maybe you could look at anti-pd1 trial so or ipi, I know they take time to work, but who knows. I truly hope and pray something will turn around for you and Don, you really have had tough breaks and deserve some good news! Take care and keep us posted. We are thinking about you and sending prayers! Valerie (phil’s wife)
                            Vermont_Donna
                            Participant

                              Dear Michelle, and Don,

                               I have no suggestions for you but wanted to say I am thinking of you both and hoping that there are some answers soon!

                              Vermont_Donna, stage 3a, NED

                              Vermont_Donna
                              Participant

                                Dear Michelle, and Don,

                                 I have no suggestions for you but wanted to say I am thinking of you both and hoping that there are some answers soon!

                                Vermont_Donna, stage 3a, NED

                              Phil S
                              Participant
                                Michelle. I am so sorry to hear that your plan B isn’t working out right now. That’s so crazy on the BRAF testing, maybe he is braf positive just not the V600?? kind they are looking for with the approved drug. I don’t know much about braf, but I am sure Dr Lawrence will have suggestions. If braf drugs are out, maybe you could look at anti-pd1 trial so or ipi, I know they take time to work, but who knows. I truly hope and pray something will turn around for you and Don, you really have had tough breaks and deserve some good news! Take care and keep us posted. We are thinking about you and sending prayers! Valerie (phil’s wife)
                                JerryfromFauq
                                Participant

                                  GSK doen't restrict the participants to the V600E BRAF mutatiion in most of their trials.  The newly approved drug is approved as listed in the FDA URL below.  There is no such thing as THE BRAF MUTATION that the news articles keep reffering to.  There is only A BRAF mutation that the drug was approved for and based on one specific BRAF mutation test for only one mutation!

                                   

                                  Here is the actual statement from the FDA http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268241.htm.

                                   

                                  See the discussion at:

                                  http://www.melanoma.org/community/mpip-melanoma-patients-information-page/inaccurate-zelboraf-approval-wording

                                  JerryfromFauq
                                  Participant

                                    GSK doen't restrict the participants to the V600E BRAF mutatiion in most of their trials.  The newly approved drug is approved as listed in the FDA URL below.  There is no such thing as THE BRAF MUTATION that the news articles keep reffering to.  There is only A BRAF mutation that the drug was approved for and based on one specific BRAF mutation test for only one mutation!

                                     

                                    Here is the actual statement from the FDA http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268241.htm.

                                     

                                    See the discussion at:

                                    http://www.melanoma.org/community/mpip-melanoma-patients-information-page/inaccurate-zelboraf-approval-wording

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