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 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 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 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 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 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 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?

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