Sunday, September 9, 2012

New informed consent for my trial..opens at least 4 slots for Stage IIIC resected melanoma patients!

Being a lab rat is a funny, rather demeaning position to be in.  Choices are participate or not.  The rat may wish to make changes in timing, requirements, pain control, information access...oh well, too bad so sad!!!!!  NOT gonna happen!  On the other hand, you may walk into the office for treatment and be handed an "updated" consent form that you have to sign for the study you are already in and have already signed an agreement for.  In other words, the rat cannot change the rules in the middle of the game...but the organization, investigator, drug company...CAN.  And so, I signed.

On the good side...the new consent is much clearer.  It makes the breakdown of the study into three groups of 10 patients understandable, stating, "one group will receive a dose of 1mg/kg, a second group a dose of 3mg/kg....." etc., rather than the vague "escalating dose" comment in the prior form.  Well, done.  I give my personal team of Brent and Ruthie, and the dedicated nurses of the CRU, full credit for that clarification!!!  HA!

It also makes it very clear that apart from a few bits of lab during screening and scattered among other visits, the leukapheresis, the peptide vaccines, and the anti-PD1 drug, BMS-936558, and your insurance company will pay in full for EVERYTHING else.  They make it clear that if you have been "injured as a result of your participation in this study," Florida law limits the liability of Moffitt in this circumstance and they will certainly NOT "pay for lost wages, disability, or discomfort."  Additionally, you should..."be aware that your health care payer/insurer might not cover the costs of study-related injuries or illnesses."

The new consent also tells us that patients like us have "a greater than 1 in 2 (50%) chance that [our] melanoma will return." And, "there is no known therapy that is likely to cure your melanoma or increase your survival. If your melanoma had spread to the lymph nodes but not other organs, then alpha interferon...could increase your survival by a small margin, about 1 in 50." This makes me bonkers!!!!!!  Does this not fly in the face of the graphs and report by Weber I just put up on the prior post?????!!!!!!

The only real and beneficial news in the NEW CONSENT is that:  NOW...this trial is open for resected stage IV melanoma patients like myself AND...STAGE IIIC RESECTED patients, as well!!!!

While, I will continue to do my best to improve the way lab rats are treated....after all...we're people too!!!!, I am glad, and consider myself "lucky", given my circumstances, to be in this trial.  The new opening for Stage IIIC patients to participate is great.  But, where the heck are the Stage IV resected peeps who could have signed up?????  I see so many demands for anti-PD1 trials on all the forums, and yet, in order to fill the seats, this trial, as well as some others at Moffitt have had to add Stage III patients to their protocols.  I really don't know the answer to my question.  Are Stage IV melanoma patients with no evidence of disease really few and far between?  Do we pass into the non-resectable category too quickly for many to make it into a trial?  Are we lackadaisical about the need for additional treatment?  Do we hide our heads under the covers and pretend that, "OK, got rid of that pesky melanoma, and am now good to go!"?  Do local oncologists mislead patients about melanoma and the odds of recurrence due to their lack of knowledge about that particular subset of cancer patients?  I don't know....but if there are some interested Stage IIIC/IV resected melanoma patients out there.....there are still some open slots (4...we were told) for you.

1 comment:

  1. Ha! Not sure which consent form is better! Oh well, you signed them both! :/