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25th infusion

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Comments

  • foxhd
    foxhd Member Posts: 3,181
    TerriNick said:

    confused

    OK, I'm confused. What is it that Fox is on that we can't get yet? And how does it work? What are the side effects or implications of treatment? Why isn't it a cure and what are the implications for the rest of the people with this illness? And I guess also when does it look likely to be available to Joe Public if it is such a good option?

    All these questions are running around in my mind. Can anyone help please?

    Terri

    Why it is not available

    Terri, I was fortunate to have stumbled upon a drug trial called MDX-1106. I was looking at certain death in a matter of months and felt that I had nothing to lose. It seems that most people still don't accept unproven treatments and the risks involved. This may delay the proof of effectiveness. It is also why it takes awhile before approval of even "miracle drugs". This drug allows my immune system to identify the cancer(and who knows what else) and attack it. I often wonder what long term side effects may come down the pike, but I am alive and prospering now. This is more than a year than expectations of my life.

    I had some guilt at first as to why I had this oppotunity while others were dieing. I asked "Why me?"  Then a friend asked me, "If you think you feel bad, think about how your doctor feels knowing that there is a drug which can save many lives and they cannot use it".

    That is what clinical trials are all about. We are research rats for the future treatment of everyone.

    Trials take many years to prove their effectiveness before being offered to the public. However, this drug may be advanced quickly and be available years ahead of many trials and they are talking about 2015.

    So do whatever it takes to stay alive, and be here for the opportunity up the road.

    One more thought, it is working for me. It does not work for everyone. Some have died. Research is progressing. I am fortunate to be a part of it. For me. And for everyone.

  • TerriNick
    TerriNick Member Posts: 43
    foxhd said:

    Why it is not available

    Terri, I was fortunate to have stumbled upon a drug trial called MDX-1106. I was looking at certain death in a matter of months and felt that I had nothing to lose. It seems that most people still don't accept unproven treatments and the risks involved. This may delay the proof of effectiveness. It is also why it takes awhile before approval of even "miracle drugs". This drug allows my immune system to identify the cancer(and who knows what else) and attack it. I often wonder what long term side effects may come down the pike, but I am alive and prospering now. This is more than a year than expectations of my life.

    I had some guilt at first as to why I had this oppotunity while others were dieing. I asked "Why me?"  Then a friend asked me, "If you think you feel bad, think about how your doctor feels knowing that there is a drug which can save many lives and they cannot use it".

    That is what clinical trials are all about. We are research rats for the future treatment of everyone.

    Trials take many years to prove their effectiveness before being offered to the public. However, this drug may be advanced quickly and be available years ahead of many trials and they are talking about 2015.

    So do whatever it takes to stay alive, and be here for the opportunity up the road.

    One more thought, it is working for me. It does not work for everyone. Some have died. Research is progressing. I am fortunate to be a part of it. For me. And for everyone.

    Inspiring

    Thank you Fox. I realise that not everything works for every person but it is great to hear good news like yours. Please continue to do

    well on MDX. You deserve a fantastic life and you are an inspiration to others. 

     

    Terri

  • todd121
    todd121 Member Posts: 1,448
    foxhd said:

    Why it is not available

    Terri, I was fortunate to have stumbled upon a drug trial called MDX-1106. I was looking at certain death in a matter of months and felt that I had nothing to lose. It seems that most people still don't accept unproven treatments and the risks involved. This may delay the proof of effectiveness. It is also why it takes awhile before approval of even "miracle drugs". This drug allows my immune system to identify the cancer(and who knows what else) and attack it. I often wonder what long term side effects may come down the pike, but I am alive and prospering now. This is more than a year than expectations of my life.

    I had some guilt at first as to why I had this oppotunity while others were dieing. I asked "Why me?"  Then a friend asked me, "If you think you feel bad, think about how your doctor feels knowing that there is a drug which can save many lives and they cannot use it".

    That is what clinical trials are all about. We are research rats for the future treatment of everyone.

    Trials take many years to prove their effectiveness before being offered to the public. However, this drug may be advanced quickly and be available years ahead of many trials and they are talking about 2015.

    So do whatever it takes to stay alive, and be here for the opportunity up the road.

    One more thought, it is working for me. It does not work for everyone. Some have died. Research is progressing. I am fortunate to be a part of it. For me. And for everyone.

    What Phase is MDX-1106?

    Fox,

    What phase trial is this?

    Todd

  • foxhd
    foxhd Member Posts: 3,181
    todd121 said:

    What Phase is MDX-1106?

    Fox,

    What phase trial is this?

    Todd

    Phase 1b

    Phase 1b, Todd. I forgot and had to think about it. I recieve 10mg/kg of body weight every 3 weeks.

  • TerriNick
    TerriNick Member Posts: 43
    foxhd said:

    Phase 1b

    Phase 1b, Todd. I forgot and had to think about it. I recieve 10mg/kg of body weight every 3 weeks.

    Trial phases

    Sorry to be dim again but what are the trial phases please? What does 1b mean? How many phases are there before something is approved?

  • MuayThaiSister
    MuayThaiSister Member Posts: 5
    Congrats Fox! Do you know the response rates seen thus far?

    25th infusion! Huge inspiration!

    My brother has been offer a spot in the  BMS anti-pd1with ipilimumab trial. His first meeting with them in Monday here in Toronto.

     

    I'm looking for personal common/umcommon side effects of pd1, and any news of response rates. since fox is such a superstar, I told my brother his experience with it.

    The max dose of pd1 is 3 mg/kg in this trial. But I have no idea what to expect when it's combined with the 1 mg yervoy infusion.

    We're excited to have the opportunity, but nervous:)

    If anyone has info to pass along, I'd be very grateful. In turn, I'll post his experiences both here and on smart patients.com.

    Kim

    Advocate and sister to Shawn, 45, mcrcc

    Radical nephrectomy 2010, Nov.

    mets to chest/abdomen found June 2012

    2 rounds of interferon

    Dec12 - present - sutent individual dose trail - 75mg. Small reduction/stability. Now showing signs of minor growth.

     

  • foxhd
    foxhd Member Posts: 3,181
    TerriNick said:

    Trial phases

    Sorry to be dim again but what are the trial phases please? What does 1b mean? How many phases are there before something is approved?

    uncertain answers

    Our smarter members are probably more exact when answering this question. Take what I say loosely.

    Research identified a molecule on our T-cells responsible for telling the T-cells (which is part of our immune system which attacks foreign viruses, bacteria, or cancer cells.) to die off when they do not have a target to destroy. Called "Programmed die off."  Next time invading cells get detected, our immune system produces killer cells and they repeat the process. Again, when they complete their job, they have nothing to do, and die. Some cancer cells have the ability to initiate this die off which allows them (cancer cells) to protect themselves. They grow and prosper. ( everyday, we have hundreds of normal cells reproducing with errors which can become cancer.)

    Alright to this point?

    Researchers found a molecule that can bind with the T-cell blocking it's programmed die off. MDX-1106, is one of them. It is an "Antibody" that can be produced in the lab. Now this T-cell remains active, and continues it''s job in destroying foreign cells (at least in the case of some kidney, skin,lung, prostate and hopefully some other cancers, this is showing promise.) The cancer cells become vulnerable and get destroyed. In our case, it is being studied for "Clear Cell Renal cancer."

    In developing a plan to try this discovery on people, they call the early stage of experiments on people "Phase 1". The phase 1 trial was to determine safe dosage to be used. I guess the dose of 10 milligrams per killigram of bodyweight is the "high" dose deemed safe at this time. This is what I am on. They also use .3, and 2 milligrams per killigram of body weight in their experiments.

    That being determined, they set new goals. They assigned people to recieve one of these 3 doses and will follow their response for up to several years depending on their response and side effects. This is "Phase 1b."

    Now here are important points.

    1, it doesn't work for everyone. So far about a 30+/- % response rate is being shown. Some have had complete response. Some partial. some no response. Why? They are looking at this. It will help to determine designer drugs in our future. I don't know what they are considering my response rate. Certainly partial so far.

    2. Long term side effects are not known. This is the risk we take. In my case I was looking at death anyway. So to me every risk was worth the try. Some people have had complications resulting in death. Pnuemonitis is one. Maybe heart, liver, thyroid, or allergic reactions may happen. Some side effects are anticipated. Obviously, many are unforseen.

    How many other phases will there be? Don't know. I don't think there is a specified number. They probably make it up as they go until the efficacy is worth the research and risks. But there is so much promise of this being a potential cure, or at least the potential to keep some cancers at a treatable and chronic condition, approvals may be pushed faster than many drugs are given. After all, it is life or death. Not heartworm. Of course it has to be a money maker for the drug companies or will be dropped in a heartbeat.

    This is a condensed version and roughly accurate. But in any case, Boy, am I lucky or what? My response is great. Side effects are not even worth mentioning. Some aches, pains, skin dryness. Maybe just my old age. Time will tell.

    The biggest message I'd like to share is for people to be more open to participating in clinical trials. Maybe 10% try unproven treatments. Too low a number considering most other treatments will probably fail with time. There are indications for each choice. We need to stay informed. We need to stay alive for the next great thing. When this was offered to me, I was not aware of it. Obviously my previous Drs. didn't know enough either.

  • Texas_wedge
    Texas_wedge Member Posts: 2,798

    Congrats Fox! Do you know the response rates seen thus far?

    25th infusion! Huge inspiration!

    My brother has been offer a spot in the  BMS anti-pd1with ipilimumab trial. His first meeting with them in Monday here in Toronto.

     

    I'm looking for personal common/umcommon side effects of pd1, and any news of response rates. since fox is such a superstar, I told my brother his experience with it.

    The max dose of pd1 is 3 mg/kg in this trial. But I have no idea what to expect when it's combined with the 1 mg yervoy infusion.

    We're excited to have the opportunity, but nervous:)

    If anyone has info to pass along, I'd be very grateful. In turn, I'll post his experiences both here and on smart patients.com.

    Kim

    Advocate and sister to Shawn, 45, mcrcc

    Radical nephrectomy 2010, Nov.

    mets to chest/abdomen found June 2012

    2 rounds of interferon

    Dec12 - present - sutent individual dose trail - 75mg. Small reduction/stability. Now showing signs of minor growth.

     

    Nivo/ipi trial

    You should get some rapid responses at Smart Patients from those already in the trial, although it's too early to get much info other than initial responses.  I believe that nivolumab is better tolerated than ipilimumab which has been in use for a little while now for metastatic melanoma. 

    Shawn is pretty tough and must be a good candidate for this very promising trial.  Has he been on the 'pulsing'  regimen of Sutent (extra-high dose -> break -> extra-high dose)?

  • Gordon Charles
    Gordon Charles Member Posts: 91
    !!!!!!!! to the FoxMan

    From one old fart to another....nice going... I see you're still taking no prisoners !

  • TerriNick
    TerriNick Member Posts: 43
    foxhd said:

    uncertain answers

    Our smarter members are probably more exact when answering this question. Take what I say loosely.

    Research identified a molecule on our T-cells responsible for telling the T-cells (which is part of our immune system which attacks foreign viruses, bacteria, or cancer cells.) to die off when they do not have a target to destroy. Called "Programmed die off."  Next time invading cells get detected, our immune system produces killer cells and they repeat the process. Again, when they complete their job, they have nothing to do, and die. Some cancer cells have the ability to initiate this die off which allows them (cancer cells) to protect themselves. They grow and prosper. ( everyday, we have hundreds of normal cells reproducing with errors which can become cancer.)

    Alright to this point?

    Researchers found a molecule that can bind with the T-cell blocking it's programmed die off. MDX-1106, is one of them. It is an "Antibody" that can be produced in the lab. Now this T-cell remains active, and continues it''s job in destroying foreign cells (at least in the case of some kidney, skin,lung, prostate and hopefully some other cancers, this is showing promise.) The cancer cells become vulnerable and get destroyed. In our case, it is being studied for "Clear Cell Renal cancer."

    In developing a plan to try this discovery on people, they call the early stage of experiments on people "Phase 1". The phase 1 trial was to determine safe dosage to be used. I guess the dose of 10 milligrams per killigram of bodyweight is the "high" dose deemed safe at this time. This is what I am on. They also use .3, and 2 milligrams per killigram of body weight in their experiments.

    That being determined, they set new goals. They assigned people to recieve one of these 3 doses and will follow their response for up to several years depending on their response and side effects. This is "Phase 1b."

    Now here are important points.

    1, it doesn't work for everyone. So far about a 30+/- % response rate is being shown. Some have had complete response. Some partial. some no response. Why? They are looking at this. It will help to determine designer drugs in our future. I don't know what they are considering my response rate. Certainly partial so far.

    2. Long term side effects are not known. This is the risk we take. In my case I was looking at death anyway. So to me every risk was worth the try. Some people have had complications resulting in death. Pnuemonitis is one. Maybe heart, liver, thyroid, or allergic reactions may happen. Some side effects are anticipated. Obviously, many are unforseen.

    How many other phases will there be? Don't know. I don't think there is a specified number. They probably make it up as they go until the efficacy is worth the research and risks. But there is so much promise of this being a potential cure, or at least the potential to keep some cancers at a treatable and chronic condition, approvals may be pushed faster than many drugs are given. After all, it is life or death. Not heartworm. Of course it has to be a money maker for the drug companies or will be dropped in a heartbeat.

    This is a condensed version and roughly accurate. But in any case, Boy, am I lucky or what? My response is great. Side effects are not even worth mentioning. Some aches, pains, skin dryness. Maybe just my old age. Time will tell.

    The biggest message I'd like to share is for people to be more open to participating in clinical trials. Maybe 10% try unproven treatments. Too low a number considering most other treatments will probably fail with time. There are indications for each choice. We need to stay informed. We need to stay alive for the next great thing. When this was offered to me, I was not aware of it. Obviously my previous Drs. didn't know enough either.

    clearer now

    Thanks Fox for the explanation. It does help and I sincerely hope that you go on enjoying the benefits of this treatment for many many years to come - until they find a cure..

    Terri :)

  • Texas_wedge
    Texas_wedge Member Posts: 2,798
    TerriNick said:

    clearer now

    Thanks Fox for the explanation. It does help and I sincerely hope that you go on enjoying the benefits of this treatment for many many years to come - until they find a cure..

    Terri :)

    clearer now

    Until they find a cure - no, Terri - let's hope that for some folks it is the cure.  Fox has done brilliantly and the fact that it's an immunomodulatory drug must hold out the hope that it could enable the body to cope with the cancer where it couldn't before getting the leg-up that the drug gives it.  Lots of hope around for us all!

  • alice124
    alice124 Member Posts: 896

    Nivo/ipi trial

    You should get some rapid responses at Smart Patients from those already in the trial, although it's too early to get much info other than initial responses.  I believe that nivolumab is better tolerated than ipilimumab which has been in use for a little while now for metastatic melanoma. 

    Shawn is pretty tough and must be a good candidate for this very promising trial.  Has he been on the 'pulsing'  regimen of Sutent (extra-high dose -> break -> extra-high dose)?

    Nivo/ipi Trial

    Kim / Tex,

    Forgive my ignorance on this trial but are the medications both delivered by infusion in this trial?

     

    Is this the same trial that Chuck (as in April and Chuck and Chuck who punched the goat) is on? I know I've been absent a bit but I haven't seen anything from them recently.

     

    Also, I see under clinical trials that John"s trial (Nivolumab/Votrient) is still listed as actively recruiting. But is that true or has this trial (Nivo/ipi) taken its place?  John's research nurse told me months ago that they were no longer recruiting for the Votrient/Nivo trial at Hopkins due to liver toxicities experienced by many patients, but it's still listed as "actively recruiting." 

  • faithlou
    faithlou Member Posts: 41
    Great News

    Great news fox!  Thank you for all the info.  Very well explained.

    Lou

  • Texas_wedge
    Texas_wedge Member Posts: 2,798
    alice124 said:

    Nivo/ipi Trial

    Kim / Tex,

    Forgive my ignorance on this trial but are the medications both delivered by infusion in this trial?

     

    Is this the same trial that Chuck (as in April and Chuck and Chuck who punched the goat) is on? I know I've been absent a bit but I haven't seen anything from them recently.

     

    Also, I see under clinical trials that John"s trial (Nivolumab/Votrient) is still listed as actively recruiting. But is that true or has this trial (Nivo/ipi) taken its place?  John's research nurse told me months ago that they were no longer recruiting for the Votrient/Nivo trial at Hopkins due to liver toxicities experienced by many patients, but it's still listed as "actively recruiting." 

    Nivo/ipi trial

    Smart patients now has several different threads all about this trial [you can probably hear my teeth grinding all the way from Scotland!] In the Clinical trials search there you'll find full details (also via the Govt. site).  On the point you've asked, Alice, the answer is :

    Experimental
    Arm I-1: Nivolumab + Ipilimumab
    Nivolumab 3 mg/kg solution intravenously (IV) every 21 days during Induction phase and every 14 days during Maintenance phase until Progressive disease (PD), toxicity or discontinue for other reasons Ipilimumab 1mg/kg solution intravenously (IV) every 21 days during Induction phase (Ipilimumab will not be administered during Maintenance phase) until Progressive disease (PD), toxicity or discontinue for other reasons

    Biological
    Nivolumab
    Other Name
    BMS-936558 (MDX-1106)
    Biological
    Ipilimumab
    Other Name
    YERVOY™
    Experimental
    Arm I-3: Nivolumab + Ipilimumab
    Nivolumab 1mg/kg solution intravenously (IV) every 21 days during Induction phase and 3mg/kg solution intravenously (IV) every 14 days during Maintenance phase Ipilimumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase. Ipilimumab will not be administered during Maintenance phase

  • Texas_wedge
    Texas_wedge Member Posts: 2,798
    faithlou said:

    Great News

    Great news fox!  Thank you for all the info.  Very well explained.

    Lou

    Better and better - nivolumab + ipilimumab

    The great promise of this trial makes it all even more exciting.  Here's an inspiring story of someone who's been on that trial for a year and a half so far and is cancer free:

    http://www.salon.com/2013/05/17/my_truly_remarkable_cancer_breakthrough/

     Just for clarity - nivolumab is the trial drug Fox is on  and ipilimumab is the already FDA-approved drug (for melanoma, trade name Yervoy) which they're trying out on other cancers, including RCC.  Both are huge molecule monoclonal antibody drugs manufactured by BMS (Bristol Myers Squibb) and Ono Pharmaceuticals.

  • NewDay
    NewDay Member Posts: 272
    Thank you to trial parcticipants

    To all of you that participate in trials:

    In the past, I contimplated whether I would participate in a trial if I needed treatment and wasn't so sure I would.  After the comments here about how this treatment is not available to all who need it, I was thinking how fortunate we are that trials are available and that some patients are willing to participate, especially after reading an article last night that emphasized how important it is to make sure that those with "unclassified" histology are excluded from trials because it muddies the waters (my paraphrase).  That means that those of us in that group are left to only the approved drugs which would never be approved were it not for those of you who can and do participate.  I know that for some the decision is easy because they have run out of options, but I believe some of them and others are also motivated by the hope that their experience will benefit others down the road.  I am NED and hope I don't ever need treatment, but if I did, my options would be with drugs that, thanks to you all, would have been tried and approved.  Although I don't need treatment, I thank you now, because knowing there are promising options coming lessens my fears now.

    And, Fox, as always, you are a, and do, ROCK!

    Kathy

  • MDCinSC
    MDCinSC Member Posts: 574
    NewDay said:

    Thank you to trial parcticipants

    To all of you that participate in trials:

    In the past, I contimplated whether I would participate in a trial if I needed treatment and wasn't so sure I would.  After the comments here about how this treatment is not available to all who need it, I was thinking how fortunate we are that trials are available and that some patients are willing to participate, especially after reading an article last night that emphasized how important it is to make sure that those with "unclassified" histology are excluded from trials because it muddies the waters (my paraphrase).  That means that those of us in that group are left to only the approved drugs which would never be approved were it not for those of you who can and do participate.  I know that for some the decision is easy because they have run out of options, but I believe some of them and others are also motivated by the hope that their experience will benefit others down the road.  I am NED and hope I don't ever need treatment, but if I did, my options would be with drugs that, thanks to you all, would have been tried and approved.  Although I don't need treatment, I thank you now, because knowing there are promising options coming lessens my fears now.

    And, Fox, as always, you are a, and do, ROCK!

    Kathy

    NED is good!

    Enough said!  But you are right, without those doing trials, the world would be a more bleak place for those of us that follow!