Friday, April 17, 2015

Clinical Trials

All around the world, people take part in clinical trials in all areas of medicine.  Clinical trials are very important because they help us learn more about diseases such as cancer. Thousands of people are helped each year because they decided to participate in a clinical trial and many more benefit from their participation.  

A clinical trial is a type of research study.  There are four main kinds of clinical trials in cancer research, those finding or improving methods for diagnosing, treating, managing, and preventing cancer. (more info: here)

I am participating in a cancer treatment trial, for the drug PrYERVOY™ (ipilimumab), affectionately referred to in my circle as "Pacmen."  I would like to put some clinical trial information in layman's terms, based on my experience.

When I first began investigating options for the treatment of my stage IIIB melanoma last spring, I was informed about three clinical trials available (at the time) for my disease. 

Soon after surgery, pathology revealed details about a specific gene in my body which meant I was unable to consider the drug on one of the trials.  Every clinical trial out there has specific requirements, not everyone can just go on whatever trial is available.

The second trial was a blind trial, meaning I had a 50/50 chance of receiving the treatment/drug on trial, or I would receive a placebo, and I would not know which one I was receiving.  I immediately ruled that out as an option, as I don't have that kind of time (or luck!) to play with. 

The third option was the one I remained interested in and eligible for, I met the criteria required for participation in the trial, and I was clearly instructed on it's history and statistics, as well as the timeline and requirements for remaining eligible for it.  

This trial was available in the U.S. and Canada, in major cancer centres, so I was lucky to be able to receive it at Sunnybrook (RVH in Barrie did not offer it).  Approximately 1500 people are in it, with it being a randomized trial, half receiving interferon, the current standard of care for stage III melanoma in Canada, and half receiving the fancy shmancy "ipi." 

After heavy review of the paperwork, a series of blood tests, and a head to toe CT scan in July, I was deemed eligible to be randomized and I remained in suspense while they decided which team I would be playing on. I believe the headquarters for this study is in Chicago? and I signed forms stating that my samples of my blood and tissues were permitted to travel there for storage and future research purposes. 

I learned that this trial would entail eight treatments of ipilimumab in total, with treatments, testing, and follow-up totaling 68 weeks.  August 2014 - November 2015.  I learned the name of the trial (MEC.3).
I was clear that I could opt-out at any time during the trial, for any reason, health-related or not, ie. if side-effects were intolerable, or for other reasons such as having the opportunity to pursue a different treatment.  In fact, 52% of participants in the higher-dose first arm of this trial did opt-out, mostly due to side-effects being experienced (risk of developing ulcerative colitis), plus a few deaths. 

I was also well aware that requirements of the trial include many blood tests and quarterly CT scans for the duration of the trial.  Part of the appeal for this trial for me was indeed the frequent CT scanning, as I had already been told they are my only way of seeing spread of the disease.   

The exposure to that much radiation and the other relative inconveniences were still worth the chance that the ipilimumab would be my life-saver... or I should say, my time-buyer. 

I signed two batches of paperwork in my oncologists' office in July and August, plus a "Consent for Chemotherapy" form on the day of my first treatment.  

When I was there for my treatment in January, I was asked to sign a new consent form, containing revised statistics on my trial.  Though it is still ongoing for those of us in the last arm, this particular clinical trial for ipi is closed to new participants. 

I look forward to seeing the final numbers on this study, but in the meantime I appreciate them being proactive and accountable for stats as they roll in.  The new consent form discussed updated side-effect numbers, specifically the occurrences of diarrhea and symptoms of colitis, as well as fatigue and mental health issues. (check! check! and check!)  
They receive these numbers during the study from consistent and regulated monitoring of patients, with office visits and other methods such as my weekly parole calls.  

And after the clinical trial?  Well, we shall see... serious advances are being made in the area of melanoma, so hopefully there will be a new treatment for me by then.  Perhaps there will be another suitable clinical trial that will help with my stage/disease?  

Based on my experience to date with this clinical trial, I would do it again.  The stress from fear of becoming ineligible is worth it, and the stress from the side-effects are from the drug itself, not from the trial.  Hopefully it will work, give me that few extra years we are hoping for.  

In any case, being as I had already made the decision that this was my best option at this time, I jumped in with both feet and here I am... still being whiny about the side-effects I am having, and still fearful of whether or not I made the right choice.  I believe that is a common ailment of cancer patients; it is a guessing game, ON a roller coaster!

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