MDX-1106 part 2

foxhd
foxhd Member Posts: 3,181
cWelcome to part 2. It should be faster to share info here. The last thread got too long. Texas Wedge asked me to review the criteria for getting into the MDX trial.

First of all it is for metastatic clear cell carcinoma only. It requires a biopsy for confirmation. I have become aware that only 80 subjects are expected to be part of this study. All of them in the United States. The study may be up to 4 years depending upon response. MDX-1106 also known as anti-PD1 and BMS-936558. Cancer cells may avoid being killed by shutting down the immune system to early. This antibody works by stopping the immune system from shutting down and allows it to continue attacking tumor cells. It might also attack normal tissues and is a potential side effect.

There are 3 dose levels. 0.3,2, and 10mg/kg. They are assigned randomly unless you have not had any previous treatments. Then 10mg/kg is the dose. It is given by IV over about an hour once every 3 weeks. Cat scans are every 6 weeks. Qualifications include: good blood chemistry including liver,kidney,white blood cells and platelets,thyroid function, hepatitis and HIV absence. Good physical condition and attitude.

Multiple cat scans, bone scans, brain scans, pet scans and 2 biopsies are required before the start.Tons of blood work. Most common side effects include: fatigue or weakness, rash, itchiness,redness,or dry skin. Diarrhea, protein in the blood, decreased white blood cell count, risk for infection and dry mouth. There may also be liver abnormalities, fever or chills, nausea, vomiting, thyroid abnormalities, shortness of breath, joint pain, headache, muscle pain, loss of appetite, arm or leg pain,cough, post nasal drip,lung inflammation,pituitary gland abnormalities and hair loss. Others include: allergic reaction to the drug,pancreas inflammation, back pain, swelling of arms and legs, heartburn, fluid accumulation in the abdomen, trouble sleeping, excessive sweating and possible risk of death. You cannot be pregnant or be breast feeding.

(Side effects sound like the grocery list of any medication you could take for anything.)

The study can be stopped at any time that your cancer worsens or if you do not tolerate the medicine or side effects. You can also drop out at any time but are required to continue with scans and blood work as required....So there is a committment if you qualify and are admitted to the study. However, I don't think there is a better alternative out there. I'll say it again that I feel extremely fortunate to be part of this study. Hail! Hail! the "Magic Bullet!"

I'll also say that besides dry skin and recent bouts of significant hip, back and chest pain, this has been real easy. I don't expect any further complications. I will also state that I currently feel excellent! Pain free. I am able to exercise and restarted my running. Psychologically I do not let any negative thoughts develope. I always think positive, have goals and plans and don't sit still for very long. Almost 5 months ago I was told that my demise could be in as little as 6 months. Believe me. Not even close. I've already booked a few motorcycle trips this summer. I also expect to play alot of golf.

My suggestion to anyone who may qualify for this study is to persue it. There can't be many openings left. For the rest of you, hang in there. We are onto something great and everyone may benefit from this soon.

Remember, FLY.

Fox loves you!!
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Comments

  • Texas_wedge
    Texas_wedge Member Posts: 2,798
    Qualification criteria
    Thanks Fox for an excellent summary and conspectus of your own experience to date. Continuing to hope it will be the complete answer for you. I was hoping it might be a possibility for me too but clear cell only rules me out. With luck it's a major step forward that could benefit many here and elsewhere too.
  • lbinmsp
    lbinmsp Member Posts: 266
    Thank you
    SO much for this information! I asked my oncologist about this and, although he is having his staff check into it, he does not feel I am a candidate. My (remaining) kidney has been cranky (as I call it) - with Creatinine levels too high and a GFR that hovers around 35. Add COPD into the mix and now liver studies going a little wonky (tumor there now too) .... well, can't hurt to ask, can it?

    I've started on Sutent now (after stereotactic radiosurgery did not give any results) - so we'll see how this goes.

    Again, thanks Fox!
  • foxhd
    foxhd Member Posts: 3,181
    lbinmsp said:

    Thank you
    SO much for this information! I asked my oncologist about this and, although he is having his staff check into it, he does not feel I am a candidate. My (remaining) kidney has been cranky (as I call it) - with Creatinine levels too high and a GFR that hovers around 35. Add COPD into the mix and now liver studies going a little wonky (tumor there now too) .... well, can't hurt to ask, can it?

    I've started on Sutent now (after stereotactic radiosurgery did not give any results) - so we'll see how this goes.

    Again, thanks Fox!

    MDX
    4th infusion today. I had been having a lot of pain previously. When I saw the Dr. today and told her I was pain free she gave me a big hug! I look forward to my next scan in 3 weeks. Lets hope these tumors are going away!
  • cww71964
    cww71964 Member Posts: 97
    foxhd said:

    MDX
    4th infusion today. I had been having a lot of pain previously. When I saw the Dr. today and told her I was pain free she gave me a big hug! I look forward to my next scan in 3 weeks. Lets hope these tumors are going away!

    mdx
    Hi Fox,

    My prayer for you is no tumors and no pain! Riding season is just around the corner and I know you will be ready.

    Health and Happiness to all,
    Wayne
  • Texas_wedge
    Texas_wedge Member Posts: 2,798
    cww71964 said:

    mdx
    Hi Fox,

    My prayer for you is no tumors and no pain! Riding season is just around the corner and I know you will be ready.

    Health and Happiness to all,
    Wayne

    MDX-1106
    Wayne - I don't suppose Fox goes riding to hounds!?

    Fox - you are going to be that poster child!
  • garym
    garym Member Posts: 1,647

    MDX-1106
    Wayne - I don't suppose Fox goes riding to hounds!?

    Fox - you are going to be that poster child!

    The fox and The hound...
    lb and fox,

    You guys never cease to amaze and inspire, your fierceness in battle is awesome!! Your willingness to share and help others along the way goes way above and beyond, from the bottom of my heart and I believe on behalf of everyone hear I'd like to say THANK YOU and keep it up!! I pray that the MDX and sutent are "magic bullets" for you and all that need them. lb, I miss the pooch pic, how about it, got another?

    Gary
  • foxhd
    foxhd Member Posts: 3,181
    garym said:

    The fox and The hound...
    lb and fox,

    You guys never cease to amaze and inspire, your fierceness in battle is awesome!! Your willingness to share and help others along the way goes way above and beyond, from the bottom of my heart and I believe on behalf of everyone hear I'd like to say THANK YOU and keep it up!! I pray that the MDX and sutent are "magic bullets" for you and all that need them. lb, I miss the pooch pic, how about it, got another?

    Gary

    MDX
    ..Is there no one else on this drug except me?
  • Texas_wedge
    Texas_wedge Member Posts: 2,798
    foxhd said:

    MDX
    ..Is there no one else on this drug except me?

    MDX
    Fox, was that meant humourously? As I understand it, there is only a very small number of people involved in the trial in the US and probably similarly in the UK. The proportion who might show up here is a matter of conjecture but I'm guessing that on CSN the answer to your question may well be 'Yes".
  • garym
    garym Member Posts: 1,647
    foxhd said:

    MDX
    ..Is there no one else on this drug except me?

    MDX...
    Nope...right now you are like that first guy that decided to pack up his covered wagon and head west...think of the rush that followed him and, I believe, you soon after. You are a pioneer in every sense of the word, the Rockies did not stop him and RCC will not stop you. Of course he got the gold and all you get is the magic bullet and Al Gore hadn't "invented" the internet yet so nobody could watch his progress the way we get to witness and root for yours.
  • foxhd
    foxhd Member Posts: 3,181
    garym said:

    MDX...
    Nope...right now you are like that first guy that decided to pack up his covered wagon and head west...think of the rush that followed him and, I believe, you soon after. You are a pioneer in every sense of the word, the Rockies did not stop him and RCC will not stop you. Of course he got the gold and all you get is the magic bullet and Al Gore hadn't "invented" the internet yet so nobody could watch his progress the way we get to witness and root for yours.

    MDX
    Wow! The pressure! the pressure! I better do good. So, I did my weight training and jogged 2 miles this morning. Must admit that I really look forward to my next scan in 2 weeks. I'm gonna get my pom poms out....
  • lbinmsp
    lbinmsp Member Posts: 266
    foxhd said:

    MDX
    ..Is there no one else on this drug except me?

    I WISH
    I was with you in this! From your detailed description, it really does sound like it could be the next great thing - far out-pacing everything that is currently available. I'm finishing my 2nd week of Sutent and although I haven't had some of the WORSE side effects, I'm having enough to make me seriously cranky! Two more weeks - ugh! BUT if it will slow this crap down a bit and I can continue to say LOUD and PROUD - N! D! Y! - I guess it'll be worth it.
  • lbinmsp
    lbinmsp Member Posts: 266
    foxhd said:

    MDX
    4th infusion today. I had been having a lot of pain previously. When I saw the Dr. today and told her I was pain free she gave me a big hug! I look forward to my next scan in 3 weeks. Lets hope these tumors are going away!

    YO FOX!
    Has your doctor given any reason for the pain? I ask because I'm just starting 3rd week of Sutent and my pain level is pretty bad. Feels like somebody has been beating on my ribs, chest and upper back with hammers! Making me seriously cranky!

    Thanks! And continued prayers for your good progress!
  • rae_rae
    rae_rae Member Posts: 300
    lbinmsp said:

    YO FOX!
    Has your doctor given any reason for the pain? I ask because I'm just starting 3rd week of Sutent and my pain level is pretty bad. Feels like somebody has been beating on my ribs, chest and upper back with hammers! Making me seriously cranky!

    Thanks! And continued prayers for your good progress!

    Ouch
    Lb,

    Sorry to hear about your side effects! Is that normal with sutent? I read a lot about the hand, foot and mouth sores and fatigue. I know my memory has been really bad this past year but I don't remember reading that! I hope it gets better for you soon. Two more weeks...it will be over before you know it.

    Rae
  • lbinmsp
    lbinmsp Member Posts: 266
    rae_rae said:

    Ouch
    Lb,

    Sorry to hear about your side effects! Is that normal with sutent? I read a lot about the hand, foot and mouth sores and fatigue. I know my memory has been really bad this past year but I don't remember reading that! I hope it gets better for you soon. Two more weeks...it will be over before you know it.

    Rae

    Rae
    I haven't read about this one either - and let me tell you - when you start on this they give you a boat-load of information covering just about everything! As far as the 'known' side effects, I've got the fatigue, sore mouth and extreme indigestion (and the worst of all - COFFEE doesn't taste good! GRRRR).. This pain thing is making me crazy! Doctor has now scheduled a bone scan to check things out. Soon I won't need to use any lamps or lights in my house - I'll light everything up all by myself!
  • rae_rae
    rae_rae Member Posts: 300
    lbinmsp said:

    Rae
    I haven't read about this one either - and let me tell you - when you start on this they give you a boat-load of information covering just about everything! As far as the 'known' side effects, I've got the fatigue, sore mouth and extreme indigestion (and the worst of all - COFFEE doesn't taste good! GRRRR).. This pain thing is making me crazy! Doctor has now scheduled a bone scan to check things out. Soon I won't need to use any lamps or lights in my house - I'll light everything up all by myself!

    Bone scan
    I hope that goes well for you. Just think...if we all got together we would be brighter than the sun!
  • foxhd
    foxhd Member Posts: 3,181
    rae_rae said:

    Bone scan
    I hope that goes well for you. Just think...if we all got together we would be brighter than the sun!

    pain
    Ibinmsp, my pain appeared to have been from bone mets, but I am now pain free.That is why I look forward to my scan in march. Could the mets really have gone away? All I know is that I feel great. Currently, the only other side effects I seem to have are occaisional bouts of fatigue and inflammed hands with peeling skin. Big deal.
  • lbinmsp
    lbinmsp Member Posts: 266
    foxhd said:

    pain
    Ibinmsp, my pain appeared to have been from bone mets, but I am now pain free.That is why I look forward to my scan in march. Could the mets really have gone away? All I know is that I feel great. Currently, the only other side effects I seem to have are occaisional bouts of fatigue and inflammed hands with peeling skin. Big deal.

    Thanks
    for your response. As for your question - I'm believing that those bone mets DID go away! This new drug may be the magic bullet so many with MRCC are waiting for.
  • lbinmsp
    lbinmsp Member Posts: 266
    foxhd said:

    pain
    Ibinmsp, my pain appeared to have been from bone mets, but I am now pain free.That is why I look forward to my scan in march. Could the mets really have gone away? All I know is that I feel great. Currently, the only other side effects I seem to have are occaisional bouts of fatigue and inflammed hands with peeling skin. Big deal.

    Thanks
    Sorry for double post - my finger got away from me!
  • BENLBENTLEY
    BENLBENTLEY Member Posts: 7
    foxhd said:

    MDX
    ..Is there no one else on this drug except me?

    MDX 1106 TRIAL
    Hello FOXHD I was scanning the net and found your post about the drug MDX 1106. I am also on a trial with MDX 1106 and it sounds like the same one. Having good reports from my scans and very little side effects. Proverbs 27:1
  • sunlover_56
    sunlover_56 Member Posts: 110
    Fox
    Hi Fox.. I am not in that trial but was asked to try Everolimus. I am stage 2 grade 1 RCC (clear) Yes I was scared of all the side effect but realize they are the same as many meds even over the oucnter drugs. The one thing that differs with the drug they want me to take is that it also kills good cells. From what I read, Everolimus can increase your risk for not only infections but also increases your risk of lymphoma and skin cancer. That is what is giving me second thought as to whether or not I want to participate. Anyone eles in this treatment with low stage RCC?