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Treatment dropped due to progression…looking for new treatment

Forums Cutaneous Melanoma Community Treatment dropped due to progression…looking for new treatment

  • Post
    EricNJill
    Participant

    Due to progression and complications during our stay for a 2nd dose of Intralymphatic Vaccine, we are stopping treatment and searching for something new.  This was at the advice of professionals.  Eric has tested positive for BRAF and they are encouraging we find a trial for BRAF but since all Eric's tumors are either vascular and sub-cutaneous we are concerned about the return of melanoma after the 8-9 months with doing PLX4032. 

    He's done the following treatments:

    HD Interferon & LD Interferon

    Due to progression and complications during our stay for a 2nd dose of Intralymphatic Vaccine, we are stopping treatment and searching for something new.  This was at the advice of professionals.  Eric has tested positive for BRAF and they are encouraging we find a trial for BRAF but since all Eric's tumors are either vascular and sub-cutaneous we are concerned about the return of melanoma after the 8-9 months with doing PLX4032. 

    He's done the following treatments:

    HD Interferon & LD Interferon

    Clinical Trial of Abraxane, Avastin & Carboplatin

    HD IL-2 (44 doses)

    Clinical Trial – Dendric Cell Vaccine

    Clinical Trial – Intralymphatic Vaccine

    Does anyone have advice on what our next step should be? 

    Thanks, Jill & Eric in OH

     

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Viewing 9 reply threads
  • Replies
      bill58
      Participant

      I am starting the BRAF trial on November 1st.  I am hoping for longer than 8-9 months of tumor shrinkage.

      Hopefully by that time, Ipi will be approved by the FDA and we can get regular dosage of that drug without being on a clinical trial or getting compassionate use.  So Ipi is my plan B,

      I dont know that much about these other clinical trials but these are some other ones I was looking at as a Plan C,D,E…

      Dinaciclib in Treating Patients With Stage IV Melanoma

      NCT ID: NCT00937937

      Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma

       

      NCT ID: NCT00715793

      Efficacy and Safety Study of OncoVEXGM-CSF Compared to GM-CSF in Melanoma

       

      NCT ID: NCT00769704

      Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma

       

      NCT ID:

      NCT01029873 – Must be HLA-A2 Positive

       

      Good luck with your search.

      Bill

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      bill58
      Participant

      I am starting the BRAF trial on November 1st.  I am hoping for longer than 8-9 months of tumor shrinkage.

      Hopefully by that time, Ipi will be approved by the FDA and we can get regular dosage of that drug without being on a clinical trial or getting compassionate use.  So Ipi is my plan B,

      I dont know that much about these other clinical trials but these are some other ones I was looking at as a Plan C,D,E…

      Dinaciclib in Treating Patients With Stage IV Melanoma

      NCT ID: NCT00937937

      Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma

       

      NCT ID: NCT00715793

      Efficacy and Safety Study of OncoVEXGM-CSF Compared to GM-CSF in Melanoma

       

      NCT ID: NCT00769704

      Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma

       

      NCT ID:

      NCT01029873 – Must be HLA-A2 Positive

       

      Good luck with your search.

      Bill

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      Jerry from Cape Cod
      Participant

      Hi Jill

      Given the same options I would do the BRAF first to give me the time to get my body in good shape for the next possible treatment.  Right now he's an excellent candidate for BRAF, there is a possibliity that may change if he waits.

      There are new treatments in the pipeline and 8-9 months could make a difference.

      It's only my 2 cents worth I can only tell you what I would do.

      Jerry from Cape Cod

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      Jerry from Cape Cod
      Participant

      Hi Jill

      Given the same options I would do the BRAF first to give me the time to get my body in good shape for the next possible treatment.  Right now he's an excellent candidate for BRAF, there is a possibliity that may change if he waits.

      There are new treatments in the pipeline and 8-9 months could make a difference.

      It's only my 2 cents worth I can only tell you what I would do.

      Jerry from Cape Cod

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      jag
      Participant

      I would look into compassionate use of ipilimumab.

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      jag
      Participant

      I would look into compassionate use of ipilimumab.

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      Jim in Denver
      Participant

      Hi Jill,

      It would make good sense to look at both a targeted treatment (assuming he is positive for the V600e mutation) as well as a systemic one for Eric.  One major issue with the Roche Trial is ramdomization, at least IMHO.  An alternative BRAF trial (Phase III, no ramdomization) is NCT01037127, which a number of people on this board are doing:

      http://clinicaltrials.gov/ct2/show/NCT01037127?term=gsk+mek&rank=5

      The targeted therapies seem to help with significant short term tumor reduction, which might be the best alternative for Eric right now, due to his large tumor burden.  The systemic approach (i.e. Compassionate Use Ipilimumab) could then become Plan B.  If he does not have the V600e, then Ipi could be Plan A.

      This is from one who has weighed the simlar decisions carefully.  Hope that helps a little, and best wishes to you both.

      Best,

      Jim

       

       

       

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        EricNJill
        Participant

        Jim,

        He is BRAF V600E positive.  I was looking at the trial on that link.  Is this a radomized trial?  It looked like someone would get the inhibitor and maybe some won't.  I'm not real good at reading those things so I could be reading it wrong.

        Thanks, Jill

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        LynnLuc
        Participant

        Perhaps this trial since it has the best of two worlds…Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma

        it's IPI and MDX 1106.,,http://www.clinicaltrials.gov/ct2/show/NCT01024231?term=MDX+1106+and+MDX+010&rank=1

        Or Perhaps 

        Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma –http://www.clinicaltrials.gov/ct2/show/NCT01024231?term=MDX+1106&rank=5
        I am stage 4 NED and currently doing " Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Stage IV Melanoma That Has Been Removed By Surgery" http://www.clinicaltrials.gov/ct2/show/NCT01176474?term=MDX+1106&rank=6
        Oct 26th will be my 7th month of NED
        Hope this helps a little…so many choices-Lynn
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        LynnLuc
        Participant

        Perhaps this trial since it has the best of two worlds…Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma

        it's IPI and MDX 1106.,,http://www.clinicaltrials.gov/ct2/show/NCT01024231?term=MDX+1106+and+MDX+010&rank=1

        Or Perhaps 

        Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma –http://www.clinicaltrials.gov/ct2/show/NCT01024231?term=MDX+1106&rank=5
        I am stage 4 NED and currently doing " Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Stage IV Melanoma That Has Been Removed By Surgery" http://www.clinicaltrials.gov/ct2/show/NCT01176474?term=MDX+1106&rank=6
        Oct 26th will be my 7th month of NED
        Hope this helps a little…so many choices-Lynn
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        Jim in Denver
        Participant

        Hi Jill,

        the trial I referenced is a Phase II Trial, none of which are randomized.  Only Phase III trials are ramdomized.  This is Glaxo's version ot the BRAF inhibitor that Roche is testing, but it is called a MEK inhibitor.  Please do not let the terminology confuse you.  If Eric has the v600e, then he is eligible, although Glaxo may want to do their own test and not accept another test.  See if there is a Site near you – maybe in the Pittsburgh area (you ar near there as I recall).

        Ther are Ipi combination trials going on, as the next poster points out.  We can discuss the options in more detail if you would like, on or off the board.  Or you can look at the Clinicaltrials.gov website.

        Best,

        Jim

         

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        EricNJill
        Participant

        Hi Jim,

        Thank you for that information.  I looked at the trial again and that is definitely something we will look into.  We actually live in Ohio, but have been traveling with Angel  Flight to Pittsburgh.  So either the Philadelphia location or the Tennessee location might work for us. 

        I also am looking into the IPI and MDX1106 trial. 

        I looked into Cisplatin, but Eric's Onc said that since he did a trial of Abraxane, Avastin & Carboplatin it wouldn't make sence to do Cisplatin because it's part of the Carboplatin family.

        I really appreciate everyone's help.   Thank you for taking the time to reply to my post.

        Jill n Eric in OH

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        LynnLuc
        Participant

        Hey Jill and Eric! I am a buckeye too! Born and raised in Tuscarawas County! (Currently hubby and I are living in North Dakota)…soon to move to Florida!)

        I am curious if Eric had a lot of sunburns growing up in Ohio…I had egg looking yellow blisters on my shoulders and neck from swimming lessons as a kid.  Mine started like a flat freckle on my neck..who would have thought it would end up being this now…! Good luck with your decision…it's always tough because once you do choose one treatment  the chances are great it will knock you out of the others…I worry about that – you know- just incase it comes back…here are 4 immunotherapies you can look at!

         

        Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

         

        Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma

         

        Tremelimumab and CP-870,893 in Patients With Metastatic Melanoma

         

        Phase I Oncovir Poly IC:LC and NY-ESO-1/gp100/MART

         

        Lynn

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        LynnLuc
        Participant

        Hey Jill and Eric! I am a buckeye too! Born and raised in Tuscarawas County! (Currently hubby and I are living in North Dakota)…soon to move to Florida!)

        I am curious if Eric had a lot of sunburns growing up in Ohio…I had egg looking yellow blisters on my shoulders and neck from swimming lessons as a kid.  Mine started like a flat freckle on my neck..who would have thought it would end up being this now…! Good luck with your decision…it's always tough because once you do choose one treatment  the chances are great it will knock you out of the others…I worry about that – you know- just incase it comes back…here are 4 immunotherapies you can look at!

         

        Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

         

        Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma

         

        Tremelimumab and CP-870,893 in Patients With Metastatic Melanoma

         

        Phase I Oncovir Poly IC:LC and NY-ESO-1/gp100/MART

         

        Lynn

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        Jim in Denver
        Participant

        Hi Jill,

        Glad id I can help in a some small way.  I should point out that the MDX 1106 trial mentioned above is a Phase I trial, so it should be evaluated accordingly.  The combination of MDX 010 (aka Ipilimumab) and MDX 1006 does look interesting, however.  I am currently enrolled in a trial of Ipi and Temazolomide, and one of those who think that Ipi combinations, as well BRAF or MEK combinations, hold promise and expect to see more of those kind of trials, hopefully sooner rather than later.

        Best wishes to you and Eric.

        Jim

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        LynnLuc
        Participant

        Temazolomide (Temodar)  lasted from my radiation in July 09 to Feb 2010. Bought me time! I am thinking if all the trials and drugs give me so many months I could last til old age. My old onc at  Mayo said I was lucky because it usually stops after 3 or 4 months. I have heard people with brain mets have been on Temazolomide for years and years and doing fine! Ted Kennedy was on it . Great success with your trial!!

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        LynnLuc
        Participant

        Temazolomide (Temodar)  lasted from my radiation in July 09 to Feb 2010. Bought me time! I am thinking if all the trials and drugs give me so many months I could last til old age. My old onc at  Mayo said I was lucky because it usually stops after 3 or 4 months. I have heard people with brain mets have been on Temazolomide for years and years and doing fine! Ted Kennedy was on it . Great success with your trial!!

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        EricNJill
        Participant

        Hi Again! 

        So the IPI and MDX 1006 being Phase One is that a bad thing?  I don't really understand this stuff.  Here was my thinking with this trial.  We can get compassionate use of IPI but when I saw it with another drug I thought that it would be best to go with the combination than just IPI alone.  I also wasn't sure if the IPI compassionate use would be covered by our insurance so I was thinking if we got into the trial for the combination it would be covered.

        Am I thinking right?

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        LynnLuc
        Participant

        I think MDX 1106 and IPI is a great thing! I am hopeful with the MDX 1106 as I am on it. It has been used with much success in other cancers  previously . Temador wasn't a big winner, but I don't thinkit was expected to be!

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        LynnLuc
        Participant

        I think MDX 1106 and IPI is a great thing! I am hopeful with the MDX 1106 as I am on it. It has been used with much success in other cancers  previously . Temador wasn't a big winner, but I don't thinkit was expected to be!

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        Jim in Denver
        Participant

        Hi Jill,

        You need to contact the hospital site or sites that is/are involved in the particular trial (in this case, Yale or MSK in NYC) and ask them if they are accepting new participants.  Do not assume that the info on the Clinicaltrials.gov website is accurate, because sometimes it is not regarding openings.  Second, try to determine if all eligibility criteria will be met to be entered in the particular trial.  So before you get too focused on a particular trial, figure out if you (Eric) is eligible and that there is a slot available first.

        Your point about the MDX 1006 is valid, and it does look like a promising combination.  Phase I trial are to determine dosages, so participants are more of a gineua pig than at Phase II trial, but that may not seem like much of an issue until you see the disclaimers the legal papers that must be signed to enroll.  If that trial is your first choice, please make sure to do your homework on that trial as well as check out other options to pursue if your first choice does not work out.  Of course, if you ask for opinions here or elsewhere (as opposed to facts), you will certainly get them, but that may not be as helpful as you would like.  There is no substitute for becoming educated yourself, even though you might prefer th rely on other people's knowledge and/or opinions.

        Regarding insurance, the cost clincal trials that do not involve FDA approved medications are covered by the sponsor(s).  MDX refers to Medarex, whihc is now owned by Bristol Meyers (BMY).  BMY covers the cost, including screenings, etc.  If you prefer to contact your carrier to verify that angle, then please do that after you know which trial Eric will be enrolling in.  Typically the study nurse at the hospital will help you with insurance so that you know if you have any cost before beginning the trial.  Last, "compassionate use"  Ipi should not cost you for the trial itself, and would still seem to be an option to consider, even if it would be Plan B or C.

        You are asking good questions, but please do not make assumptions and do verify any information you get on this board – including from me!

        Best Wishes,

        Jim

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        LynnLuc
        Participant

        Yes My trial is covered by the trial but my insurance had to pay for the initial scans and initial dr visit. Once accepted into the trial every thing is covered. They say if it's a standard treatment that I would normally happen outside of the trial insurance would be responsible.

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        LynnLuc
        Participant

        Yes My trial is covered by the trial but my insurance had to pay for the initial scans and initial dr visit. Once accepted into the trial every thing is covered. They say if it's a standard treatment that I would normally happen outside of the trial insurance would be responsible.

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        EricNJill
        Participant

        Thank you all for your help.  I did contact MSK and it looks like the trial is full.  They said it's on hold and they have a large waiting list so I got the impression that it would be full so know I'm looking at the GSK MEK Inhibitor Trial.  Is that similar to the BRAF PLX4032 drug? 

        I always thought I was a pretty smart gal but when I look at these clinical trials I get so overwhelmed.  I really wish I understood these better because I feel like I could help him more if I really understood them.  I called Nashville because they had the phase 2 trail for the BRAF GSK MEK inhibitor, but the lady was trying to get me into a GSK Phase 1 trial.  I was so confused.

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        James from Sydney
        Participant

        Hi Jill

        Generally Phase 1 is trialing the drug where sometimes phase 2 is the Trial Drug or placebo. She probably wants to make sure you get the drug. Ask her if this is the case.

        best wishes

        James

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        James from Sydney
        Participant

        Hi Jill

        Generally Phase 1 is trialing the drug where sometimes phase 2 is the Trial Drug or placebo. She probably wants to make sure you get the drug. Ask her if this is the case.

        best wishes

        James

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        EricNJill
        Participant

        Thank you all for your help.  I did contact MSK and it looks like the trial is full.  They said it's on hold and they have a large waiting list so I got the impression that it would be full so know I'm looking at the GSK MEK Inhibitor Trial.  Is that similar to the BRAF PLX4032 drug? 

        I always thought I was a pretty smart gal but when I look at these clinical trials I get so overwhelmed.  I really wish I understood these better because I feel like I could help him more if I really understood them.  I called Nashville because they had the phase 2 trail for the BRAF GSK MEK inhibitor, but the lady was trying to get me into a GSK Phase 1 trial.  I was so confused.

        Loading spinner
        Jim in Denver
        Participant

        Hi Jill,

        You need to contact the hospital site or sites that is/are involved in the particular trial (in this case, Yale or MSK in NYC) and ask them if they are accepting new participants.  Do not assume that the info on the Clinicaltrials.gov website is accurate, because sometimes it is not regarding openings.  Second, try to determine if all eligibility criteria will be met to be entered in the particular trial.  So before you get too focused on a particular trial, figure out if you (Eric) is eligible and that there is a slot available first.

        Your point about the MDX 1006 is valid, and it does look like a promising combination.  Phase I trial are to determine dosages, so participants are more of a gineua pig than at Phase II trial, but that may not seem like much of an issue until you see the disclaimers the legal papers that must be signed to enroll.  If that trial is your first choice, please make sure to do your homework on that trial as well as check out other options to pursue if your first choice does not work out.  Of course, if you ask for opinions here or elsewhere (as opposed to facts), you will certainly get them, but that may not be as helpful as you would like.  There is no substitute for becoming educated yourself, even though you might prefer th rely on other people's knowledge and/or opinions.

        Regarding insurance, the cost clincal trials that do not involve FDA approved medications are covered by the sponsor(s).  MDX refers to Medarex, whihc is now owned by Bristol Meyers (BMY).  BMY covers the cost, including screenings, etc.  If you prefer to contact your carrier to verify that angle, then please do that after you know which trial Eric will be enrolling in.  Typically the study nurse at the hospital will help you with insurance so that you know if you have any cost before beginning the trial.  Last, "compassionate use"  Ipi should not cost you for the trial itself, and would still seem to be an option to consider, even if it would be Plan B or C.

        You are asking good questions, but please do not make assumptions and do verify any information you get on this board – including from me!

        Best Wishes,

        Jim

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        EricNJill
        Participant

        Hi Again! 

        So the IPI and MDX 1006 being Phase One is that a bad thing?  I don't really understand this stuff.  Here was my thinking with this trial.  We can get compassionate use of IPI but when I saw it with another drug I thought that it would be best to go with the combination than just IPI alone.  I also wasn't sure if the IPI compassionate use would be covered by our insurance so I was thinking if we got into the trial for the combination it would be covered.

        Am I thinking right?

        Loading spinner
        Jim in Denver
        Participant

        Hi Jill,

        Glad id I can help in a some small way.  I should point out that the MDX 1106 trial mentioned above is a Phase I trial, so it should be evaluated accordingly.  The combination of MDX 010 (aka Ipilimumab) and MDX 1006 does look interesting, however.  I am currently enrolled in a trial of Ipi and Temazolomide, and one of those who think that Ipi combinations, as well BRAF or MEK combinations, hold promise and expect to see more of those kind of trials, hopefully sooner rather than later.

        Best wishes to you and Eric.

        Jim

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        EricNJill
        Participant

        Hi Jim,

        Thank you for that information.  I looked at the trial again and that is definitely something we will look into.  We actually live in Ohio, but have been traveling with Angel  Flight to Pittsburgh.  So either the Philadelphia location or the Tennessee location might work for us. 

        I also am looking into the IPI and MDX1106 trial. 

        I looked into Cisplatin, but Eric's Onc said that since he did a trial of Abraxane, Avastin & Carboplatin it wouldn't make sence to do Cisplatin because it's part of the Carboplatin family.

        I really appreciate everyone's help.   Thank you for taking the time to reply to my post.

        Jill n Eric in OH

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        Jim in Denver
        Participant

        Hi Jill,

        the trial I referenced is a Phase II Trial, none of which are randomized.  Only Phase III trials are ramdomized.  This is Glaxo's version ot the BRAF inhibitor that Roche is testing, but it is called a MEK inhibitor.  Please do not let the terminology confuse you.  If Eric has the v600e, then he is eligible, although Glaxo may want to do their own test and not accept another test.  See if there is a Site near you – maybe in the Pittsburgh area (you ar near there as I recall).

        Ther are Ipi combination trials going on, as the next poster points out.  We can discuss the options in more detail if you would like, on or off the board.  Or you can look at the Clinicaltrials.gov website.

        Best,

        Jim

         

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        EricNJill
        Participant

        Jim,

        He is BRAF V600E positive.  I was looking at the trial on that link.  Is this a radomized trial?  It looked like someone would get the inhibitor and maybe some won't.  I'm not real good at reading those things so I could be reading it wrong.

        Thanks, Jill

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      Jim in Denver
      Participant

      Hi Jill,

      It would make good sense to look at both a targeted treatment (assuming he is positive for the V600e mutation) as well as a systemic one for Eric.  One major issue with the Roche Trial is ramdomization, at least IMHO.  An alternative BRAF trial (Phase III, no ramdomization) is NCT01037127, which a number of people on this board are doing:

      http://clinicaltrials.gov/ct2/show/NCT01037127?term=gsk+mek&rank=5

      The targeted therapies seem to help with significant short term tumor reduction, which might be the best alternative for Eric right now, due to his large tumor burden.  The systemic approach (i.e. Compassionate Use Ipilimumab) could then become Plan B.  If he does not have the V600e, then Ipi could be Plan A.

      This is from one who has weighed the simlar decisions carefully.  Hope that helps a little, and best wishes to you both.

      Best,

      Jim

       

       

       

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      mrsmarilyn
      Participant

      Hi-Try Nashville Sara Cannon – they have alot of new targeted trials.  My brother is having great success there- he goes there every three weeks from Florida- but it has saved his life so far on B-raf inhibitor – GSK.  The place is so very positive and amazing.  I wish Eric and you best of luck – we felt hopeless 9 months ago. Just FYI- my brother was a Braf-K type — even though they were looking for a different Braf – I think V- it still has been a miracle!  Keep looking -don't ever give up.

      Best wishes

      MrsMarilyn

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        EricNJill
        Participant

        Mrs. Marilyn.  Thank you so much for your post.  We actually did check there and sent over Eric's file yesterday.  They called me this morning and are going to have someone call us to set up an appointment.  Do you know the name of the doctor your brother is seeing?  I'd love to learn more about your brother, if you don't mind.  You can email me at [email protected].

         

        Thank YOU!

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        EricNJill
        Participant

        Mrs. Marilyn.  Thank you so much for your post.  We actually did check there and sent over Eric's file yesterday.  They called me this morning and are going to have someone call us to set up an appointment.  Do you know the name of the doctor your brother is seeing?  I'd love to learn more about your brother, if you don't mind.  You can email me at [email protected].

         

        Thank YOU!

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      mrsmarilyn
      Participant

      Hi-Try Nashville Sara Cannon – they have alot of new targeted trials.  My brother is having great success there- he goes there every three weeks from Florida- but it has saved his life so far on B-raf inhibitor – GSK.  The place is so very positive and amazing.  I wish Eric and you best of luck – we felt hopeless 9 months ago. Just FYI- my brother was a Braf-K type — even though they were looking for a different Braf – I think V- it still has been a miracle!  Keep looking -don't ever give up.

      Best wishes

      MrsMarilyn

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