MRF-Logo2019-Horizontal-RGB
Ridiculous trial troubles, part deux
REGISTER
The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. Content within the patient forum is user-generated and has not been reviewed by medical professionals. Other sections of the Melanoma Research Foundation website include information that has been reviewed by medical professionals as appropriate. All medical decisions should be made in consultation with your doctor or other qualified medical professional.

Ridiculous trial troubles, part deux

› Forums › General Melanoma Community › Ridiculous trial troubles, part deux

  • Post
    • August 20, 2011 at 2:14 am
    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
        • August 20, 2011 at 5:30 am
        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.

          • August 20, 2011 at 5:30 am
          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.

            • August 20, 2011 at 5:30 am
            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.

              • August 20, 2011 at 5:30 am
              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.

                • August 20, 2011 at 5:30 am
                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.

                  • August 20, 2011 at 5:30 am
                  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.

                    • August 20, 2011 at 10:03 am
                    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

                      • August 20, 2011 at 10:03 am
                      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

                        • August 20, 2011 at 1:20 pm
                        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)
                            • August 21, 2011 at 12:45 pm
                            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

                              • August 21, 2011 at 12:45 pm
                              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

                              • August 20, 2011 at 1:20 pm
                              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)
                                • August 24, 2011 at 4:31 am
                                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

                                  • August 24, 2011 at 4:31 am
                                  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

                                Viewing 11 reply threads
                                • You must be logged in to reply to this topic.
                                About the MRF Patient Forum

                                The MRF Patient Forum is the oldest and largest online community of people affected by melanoma. It is designed to provide peer support and information to caregivers, patients, family and friends. There is no better place to discuss different parts of your journey with this cancer and find the friends and support resources to make that journey more bearable.

                                The information on the forum is open and accessible to everyone. To add a new topic or to post a reply, you must be a registered user. Please note that you will be able to post both topics and replies anonymously even though you are logged in. All posts must abide by MRF posting policies.

                                Popular Topics