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Problems with clinical trials
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Problems with clinical trials

› Forums › General Melanoma Community › Problems with clinical trials

  • Post
    • May 25, 2011 at 3:54 am
    mahdusia
    Participant

      Hi,

      I have a problem with getting directly to main investigators/people responsible for running clinical trials. My father is stage IV, with mets in brain and critical condition of liver. Our doctor proposed the mixed chemotherapy, which I think is a last resort in this case, convincing us there is no possibility to get e.g. PLX4032. I was trying to find some information about PLX via Genentech, but the only answer I got was "please contact your physician or Roche", and for the application forms to Roche nobody has yet answered (sent 5 days ago)

      Hi,

      I have a problem with getting directly to main investigators/people responsible for running clinical trials. My father is stage IV, with mets in brain and critical condition of liver. Our doctor proposed the mixed chemotherapy, which I think is a last resort in this case, convincing us there is no possibility to get e.g. PLX4032. I was trying to find some information about PLX via Genentech, but the only answer I got was "please contact your physician or Roche", and for the application forms to Roche nobody has yet answered (sent 5 days ago)

      Does anybody have any direct contact to hospitals/people and also requirements to be approved for PLX4032 clinical trials? I'd be absolutely grateful for information.

    Viewing 11 reply threads
    • Replies
        • May 25, 2011 at 5:30 am
        Gene_S
        Participant

          Going by the limited info that you posted, I assume that your father is being treated by a "general or local" oncologist. A "melanoma specialist" oncologist would know how to get him into a clinical trail for PLX4032 or ippi. Keep in mind that brain mets have different rules for qualifying for a drug trail. If it was my father, I would get a second opinion from a "melanoma specialist".

          Best Wishes,

          Gene

          • May 25, 2011 at 5:30 am
          Gene_S
          Participant

            Going by the limited info that you posted, I assume that your father is being treated by a "general or local" oncologist. A "melanoma specialist" oncologist would know how to get him into a clinical trail for PLX4032 or ippi. Keep in mind that brain mets have different rules for qualifying for a drug trail. If it was my father, I would get a second opinion from a "melanoma specialist".

            Best Wishes,

            Gene

            • May 25, 2011 at 11:59 am
            MichaelFL
            Participant

              Hi, and welcome to the forum that no one wants to be a member of by choice.

              To qualify for the PLX4032 trials,  (also called RO5185426) a sample of the tumor has to be tested for and be positive for what is called the BRAF V600E mutation.

              I looked at clinicaltrials.gov, and here are the two PLX4032 trials if you wish to read up on them:

              http://clinicaltrials.gov/ct2/results?term=plx4032+melanoma&recr=Open

              Sad to say though that having brain mets is also part of the exclusion criteria, so that is most likely one of the main reasons why the doctor decided to go another route with mixed chemo instead.

              As Gene said, a doctor at a melanoma center of excellence would be better able to assist you as well.

              Here are the ones for NY:

              NEW YORK

              Cancer Research Center
              Albert Einstein College of Medicine
              Chanin Building, Room 209
              1300 Morris Park Avenue
              Bronx, New York 10461
              (718) 430-2302
              David Goldman, M.D., Director

              Roswell Park Cancer Institute
              Elm & Carlton Streets
              Buffalo, New York 14263-0001
              (716) 845-5772
              David C. Hohn, M.D., President & CEO
              Nathalie Zeitouni, MD (Dermatology)

              Cold Spring Harbor Laboratory
              P.O. Box 100
              Cold Spring Harbor, New York 11724
              (516) 367-8383
              Bruce W. Stillman, Ph.D., Director

              NYU Cancer Institute
              New York University Medical Center
              550 First Avenue
              New York, New York 10016
              (212) 263-8950
              Steven J. Burakoff, M.D., Director

              Memorial Sloan-Kettering Cancer Center
              1275 York Avenue
              New York, New York 10021
              (212) 639-2000 or (800) 525-2225
              Harold E. Varmus, M.D., President & CEO
              Allan Halpern, MD, Chief, Dermatology

              Herbert Irving Comprehensive Cancer Center
              Columbia University Medical Center
              1130 St. Nicholas Avenue
              11Suite 201
              New York, New York 10032
              (212) 851-4680
              Riccardo Dalla-Favera, M.D., Director

              James P. Wilmot Cancer Center
              University of Rochester Medical Center
              601 Elmwood Ave. Box 704
              Rochester NY 14642
              (866) 4-WILMOT
              (585) 275-5830

              Herbert Irving Comprehensive Cancer Center
              New York-Presbyterian Hospital
              161 Fort Washington Avenue
              11th Floor, Room 1153, New York, NY 10032
              (877) 697-9355 (1-877-NYP-WELL)
              (800) 227-2762 (Physician Referral)

              Sorry I could not be of more assistance,

              Michael

               

                • May 25, 2011 at 2:36 pm
                dian in spokane
                Participant

                  Michael..thanks so much for your great support on this site. It amazes me that you always manage to come through with this sort of information

                  • May 25, 2011 at 2:36 pm
                  dian in spokane
                  Participant

                    Michael..thanks so much for your great support on this site. It amazes me that you always manage to come through with this sort of information

                  • May 25, 2011 at 11:59 am
                  MichaelFL
                  Participant

                    Hi, and welcome to the forum that no one wants to be a member of by choice.

                    To qualify for the PLX4032 trials,  (also called RO5185426) a sample of the tumor has to be tested for and be positive for what is called the BRAF V600E mutation.

                    I looked at clinicaltrials.gov, and here are the two PLX4032 trials if you wish to read up on them:

                    http://clinicaltrials.gov/ct2/results?term=plx4032+melanoma&recr=Open

                    Sad to say though that having brain mets is also part of the exclusion criteria, so that is most likely one of the main reasons why the doctor decided to go another route with mixed chemo instead.

                    As Gene said, a doctor at a melanoma center of excellence would be better able to assist you as well.

                    Here are the ones for NY:

                    NEW YORK

                    Cancer Research Center
                    Albert Einstein College of Medicine
                    Chanin Building, Room 209
                    1300 Morris Park Avenue
                    Bronx, New York 10461
                    (718) 430-2302
                    David Goldman, M.D., Director

                    Roswell Park Cancer Institute
                    Elm & Carlton Streets
                    Buffalo, New York 14263-0001
                    (716) 845-5772
                    David C. Hohn, M.D., President & CEO
                    Nathalie Zeitouni, MD (Dermatology)

                    Cold Spring Harbor Laboratory
                    P.O. Box 100
                    Cold Spring Harbor, New York 11724
                    (516) 367-8383
                    Bruce W. Stillman, Ph.D., Director

                    NYU Cancer Institute
                    New York University Medical Center
                    550 First Avenue
                    New York, New York 10016
                    (212) 263-8950
                    Steven J. Burakoff, M.D., Director

                    Memorial Sloan-Kettering Cancer Center
                    1275 York Avenue
                    New York, New York 10021
                    (212) 639-2000 or (800) 525-2225
                    Harold E. Varmus, M.D., President & CEO
                    Allan Halpern, MD, Chief, Dermatology

                    Herbert Irving Comprehensive Cancer Center
                    Columbia University Medical Center
                    1130 St. Nicholas Avenue
                    11Suite 201
                    New York, New York 10032
                    (212) 851-4680
                    Riccardo Dalla-Favera, M.D., Director

                    James P. Wilmot Cancer Center
                    University of Rochester Medical Center
                    601 Elmwood Ave. Box 704
                    Rochester NY 14642
                    (866) 4-WILMOT
                    (585) 275-5830

                    Herbert Irving Comprehensive Cancer Center
                    New York-Presbyterian Hospital
                    161 Fort Washington Avenue
                    11th Floor, Room 1153, New York, NY 10032
                    (877) 697-9355 (1-877-NYP-WELL)
                    (800) 227-2762 (Physician Referral)

                    Sorry I could not be of more assistance,

                    Michael

                     

                    • May 25, 2011 at 6:03 pm
                    rbruce
                    Participant

                      What drugs are in the "mixed chemo" you mention?  There are some pretty good combos out there that may slow the progression enough to be able to make some informed choices.   Robert

                      • May 25, 2011 at 6:03 pm
                      rbruce
                      Participant

                        What drugs are in the "mixed chemo" you mention?  There are some pretty good combos out there that may slow the progression enough to be able to make some informed choices.   Robert

                        • May 25, 2011 at 6:15 pm
                        Cooper
                        Participant

                          Unfortunately your father probably wouldn't qualify because of his brain mets, but call the trial coordinator to find out.  He also needs a certain mobility to qualify too..call about the open access trials too.

                          • May 25, 2011 at 6:15 pm
                          Cooper
                          Participant

                            Unfortunately your father probably wouldn't qualify because of his brain mets, but call the trial coordinator to find out.  He also needs a certain mobility to qualify too..call about the open access trials too.

                            • May 26, 2011 at 3:37 pm
                            JuliaZ
                            Participant

                              For PLX 4032 – study ID number is ML25597. You can google it. This is a last trial that is being offered for this medication.

                              Trial site are:

                              Sarah Cannon Research Institute (Tennessee Oncology)
                              Nashville, TN
                              Investigator: John Hainsworth
                              Phone number: 1-877-691-7274

                              Karmanos Cancer Center
                              Detroit, MI
                              Investigator:  Lawrence Flaherty
                              Coordinator:  Lisa Kolomyski
                              Phone number:  313-576-9386

                              The Angeles Clinic and Research Center
                              Los Angeles, CA
                              Investigator:  Steven O’Day
                              Coordinator:  Gina Deck
                              Phone number: 310-231-2121

                              UCLA Department of Medicine
                              Los Angeles, CA
                              Investigator: Antoni Ribas
                              Coordinator:  Liz Seja
                              Phone Number:  310-794-6892

                              Providence Portland Medical Center
                              Portland, OR
                              Investigator:  Brendan Curti
                              Coordinator:  Christopher Fountain
                              Phone Number:  503-215-2691

                              South Carolina Oncology
                              Columbia, South Carolina
                              Investigator: Dr. Kudirk
                              Coordinators:
                              Primary: Sue Modugno 803-461-3090
                              Secondary: Pam Tims. 803-461-3089

                              Virginia Cancer Institute
                              Richmond, VA
                              Investigator: Dr. Khatcheressian
                              Coordinator:  Vicki Tolbert
                              Phone Number: 804-287-3000

                              Texas Oncology, PA
                              Dallas, TX
                              Investigator:  Dr. Cowey Lance
                              Administrator: Rosanna Quiroz
                              Phone Number:  214-370-1986

                              Florida Cancer Specialists
                              Ft. Meyers, FL
                              Investigator:  Dr. Robert Weaver
                              Coordinator:  Cara O’Keefe
                              239-274-9930

                              Oncology & Hematology Care, Inc.
                              Cincinnati, OH
                              Investigator:  Dr.  Peter Ruehlman
                              Coordinator:  Ann Bradley
                              Phone: 513-751-2273

                              University of Pennsylvania
                              Philadelphia, PA
                              Investigator:  Dr. Lynn Schuchter
                              Coordinator:  Joanne Ciconte
                              Phone: 215-349-8622

                              Washington University School of Medicine
                              St. Louis, MO
                              Investigator:  Gerald Linette
                              Coordinator:  Chloe Fournier
                              Phone: 314-747-4235

                              There is exclusion for people with activity in the brain. But once it get treated with radiology and there is no new progress, then patient can qualify.

                              Plexxikon apllied for FDA approval for PLX 4032 on May 12. Once it will be approved it will be widely available.

                              Best wishes.

                                • May 31, 2011 at 12:08 pm
                                mahdusia
                                Participant

                                  Big thanks to all for sending me the additional info. I will go through all the sites and check whether sg is available for him.

                                  Answering all the questions I got:

                                  – my father was treated by the doctor, who is quite famous melanoma specialist and I am pretty disappointed in his approach. I just got the feeling that he sticks to the methods which are "officially accepted" and doesn't want to take the risk of trying something new. In the situation when you practically have nothing to lose, he should have been a little more flexible. As a result, I am searching all the databases for clinical trials without any professional support.

                                  – the mixed chemo we were proposed is: cisplastin, vinblastin, and temozolomide.

                                   

                                  • May 31, 2011 at 1:26 pm
                                  FormerCaregiver
                                  Participant

                                    Welcome to our forum. I would just like to give my view on your father's situation. You
                                    mentioned that he has mets in the brain, but I am more concerned about his liver at the
                                    moment.

                                    If he has had liver function tests done recently, what do they show? I ask this because
                                    the treatment that he will receive has to be chosen carefully, so that his liver is able
                                    to cope.

                                    Have you asked your doctor about Yervoy (ipilimumab)?

                                    Best wishes

                                    Frank from Australia

                                    • May 31, 2011 at 11:45 pm
                                    mahdusia
                                    Participant

                                      Frank,

                                      we checked the liver functions almost day by day and it's not that bad (ALT, AST, LDH over the limit, but it's less than a week ago).

                                      the problem with Yervoy, in opinion of my doctor, was my father's brain surgery two weeks ago

                                      the doctor told us that after the craniotomy (one of tumors ulcerated, another, very small, still in there) there is a big risk of stroke while taking Yervoy and refused to give him that medicine 🙁

                                      • June 1, 2011 at 12:59 pm
                                      FormerCaregiver
                                      Participant

                                        I can now see why the doctor rejected Yervoy. Bleeding is possible, if there is any
                                        inflammation of the liver. Here is a link to the side effects:
                                        http://www.drugs.com/yervoy.html

                                        Best wishes

                                        Frank from Australia

                                        • June 1, 2011 at 12:59 pm
                                        FormerCaregiver
                                        Participant

                                          I can now see why the doctor rejected Yervoy. Bleeding is possible, if there is any
                                          inflammation of the liver. Here is a link to the side effects:
                                          http://www.drugs.com/yervoy.html

                                          Best wishes

                                          Frank from Australia

                                          • May 31, 2011 at 11:45 pm
                                          mahdusia
                                          Participant

                                            Frank,

                                            we checked the liver functions almost day by day and it's not that bad (ALT, AST, LDH over the limit, but it's less than a week ago).

                                            the problem with Yervoy, in opinion of my doctor, was my father's brain surgery two weeks ago

                                            the doctor told us that after the craniotomy (one of tumors ulcerated, another, very small, still in there) there is a big risk of stroke while taking Yervoy and refused to give him that medicine 🙁

                                            • May 31, 2011 at 1:26 pm
                                            FormerCaregiver
                                            Participant

                                              Welcome to our forum. I would just like to give my view on your father's situation. You
                                              mentioned that he has mets in the brain, but I am more concerned about his liver at the
                                              moment.

                                              If he has had liver function tests done recently, what do they show? I ask this because
                                              the treatment that he will receive has to be chosen carefully, so that his liver is able
                                              to cope.

                                              Have you asked your doctor about Yervoy (ipilimumab)?

                                              Best wishes

                                              Frank from Australia

                                              • May 31, 2011 at 12:08 pm
                                              mahdusia
                                              Participant

                                                Big thanks to all for sending me the additional info. I will go through all the sites and check whether sg is available for him.

                                                Answering all the questions I got:

                                                – my father was treated by the doctor, who is quite famous melanoma specialist and I am pretty disappointed in his approach. I just got the feeling that he sticks to the methods which are "officially accepted" and doesn't want to take the risk of trying something new. In the situation when you practically have nothing to lose, he should have been a little more flexible. As a result, I am searching all the databases for clinical trials without any professional support.

                                                – the mixed chemo we were proposed is: cisplastin, vinblastin, and temozolomide.

                                                 

                                              • May 26, 2011 at 3:37 pm
                                              JuliaZ
                                              Participant

                                                For PLX 4032 – study ID number is ML25597. You can google it. This is a last trial that is being offered for this medication.

                                                Trial site are:

                                                Sarah Cannon Research Institute (Tennessee Oncology)
                                                Nashville, TN
                                                Investigator: John Hainsworth
                                                Phone number: 1-877-691-7274

                                                Karmanos Cancer Center
                                                Detroit, MI
                                                Investigator:  Lawrence Flaherty
                                                Coordinator:  Lisa Kolomyski
                                                Phone number:  313-576-9386

                                                The Angeles Clinic and Research Center
                                                Los Angeles, CA
                                                Investigator:  Steven O’Day
                                                Coordinator:  Gina Deck
                                                Phone number: 310-231-2121

                                                UCLA Department of Medicine
                                                Los Angeles, CA
                                                Investigator: Antoni Ribas
                                                Coordinator:  Liz Seja
                                                Phone Number:  310-794-6892

                                                Providence Portland Medical Center
                                                Portland, OR
                                                Investigator:  Brendan Curti
                                                Coordinator:  Christopher Fountain
                                                Phone Number:  503-215-2691

                                                South Carolina Oncology
                                                Columbia, South Carolina
                                                Investigator: Dr. Kudirk
                                                Coordinators:
                                                Primary: Sue Modugno 803-461-3090
                                                Secondary: Pam Tims. 803-461-3089

                                                Virginia Cancer Institute
                                                Richmond, VA
                                                Investigator: Dr. Khatcheressian
                                                Coordinator:  Vicki Tolbert
                                                Phone Number: 804-287-3000

                                                Texas Oncology, PA
                                                Dallas, TX
                                                Investigator:  Dr. Cowey Lance
                                                Administrator: Rosanna Quiroz
                                                Phone Number:  214-370-1986

                                                Florida Cancer Specialists
                                                Ft. Meyers, FL
                                                Investigator:  Dr. Robert Weaver
                                                Coordinator:  Cara O’Keefe
                                                239-274-9930

                                                Oncology & Hematology Care, Inc.
                                                Cincinnati, OH
                                                Investigator:  Dr.  Peter Ruehlman
                                                Coordinator:  Ann Bradley
                                                Phone: 513-751-2273

                                                University of Pennsylvania
                                                Philadelphia, PA
                                                Investigator:  Dr. Lynn Schuchter
                                                Coordinator:  Joanne Ciconte
                                                Phone: 215-349-8622

                                                Washington University School of Medicine
                                                St. Louis, MO
                                                Investigator:  Gerald Linette
                                                Coordinator:  Chloe Fournier
                                                Phone: 314-747-4235

                                                There is exclusion for people with activity in the brain. But once it get treated with radiology and there is no new progress, then patient can qualify.

                                                Plexxikon apllied for FDA approval for PLX 4032 on May 12. Once it will be approved it will be widely available.

                                                Best wishes.

                                                • May 31, 2011 at 12:38 pm
                                                shellebrownies
                                                Participant

                                                  I was informed by my husbands oncologist that there is a Compassionate use trial coming soon for the PLX 4032, but I do not know what the exclusion criteria would be for that one.

                                                  Michelle, wife of Don, Stage IV

                                                    • May 31, 2011 at 11:51 pm
                                                    mahdusia
                                                    Participant

                                                      Michelle,

                                                      that is thrilling news! Would you be so kind to give me some direct contact/site where this trial is going to be organized?

                                                      And also one, maybe silly question. I am not the native English-speaker and I am not familiar with the practical meaning of word "compassionate" in terms of clinical trials…

                                                      Could you please explain me how it works?

                                                      • June 1, 2011 at 12:43 am
                                                      Gene_S
                                                      Participant

                                                        RE: I am not the native English-speaker and I am not familiar with the practical meaning of word "compassionate" in terms of clinical trials…    see:

                                                        http://www.cancer.org/Treatment/TreatmentsandSideEffects/ClinicalTrials/compassionate-drug-use

                                                        Best wishes,

                                                        Gene

                                                        • June 1, 2011 at 12:43 am
                                                        Gene_S
                                                        Participant

                                                          RE: I am not the native English-speaker and I am not familiar with the practical meaning of word "compassionate" in terms of clinical trials…    see:

                                                          http://www.cancer.org/Treatment/TreatmentsandSideEffects/ClinicalTrials/compassionate-drug-use

                                                          Best wishes,

                                                          Gene

                                                          • May 31, 2011 at 11:51 pm
                                                          mahdusia
                                                          Participant

                                                            Michelle,

                                                            that is thrilling news! Would you be so kind to give me some direct contact/site where this trial is going to be organized?

                                                            And also one, maybe silly question. I am not the native English-speaker and I am not familiar with the practical meaning of word "compassionate" in terms of clinical trials…

                                                            Could you please explain me how it works?

                                                          • May 31, 2011 at 12:38 pm
                                                          shellebrownies
                                                          Participant

                                                            I was informed by my husbands oncologist that there is a Compassionate use trial coming soon for the PLX 4032, but I do not know what the exclusion criteria would be for that one.

                                                            Michelle, wife of Don, Stage IV

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