Feb 11, 2012 - 11:27 am
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.
Fox loves you!!