I think technically the thing I participated in was/is a study — not a trial.
Although I’m not sure if there’s a difference or not. Because it was a only Phase 1 of this particular study it’s not known whether it works or not. Phase 1 study just determine safety/toxicity. It has been tried with other types of cancer tumors with some degree of success. It’s not something that’ll help me in the future because I had an early RC for T1G3 — so the tumor is gone (hopefully never to return in other places). But, who knows, with it in my system it definitely won’t hurt to have those dendritic cells on patrol for a systemic recurrence.
My participation in the study included me first getting several injections in my forearms to test my immune response… kind of like an allergy skin test. If it wasn’t adequate then they’d kick me out of the study. I passed that test. Then they did a TURB (my second in a month) with the sole purpose of obtaining tumor tissue. I also went through luekapherisis (sp?) which seemed similar to dialysis. It was 4 hours of needles in both arms while a machine pumped my blood out of me, separated the dendritic cells from my white blood cells, and then returned me my scrubbed blood. Besides the RC, it was probably the most unpleasant part of the study. After that I got my own personal vaccine injection once per week for 4 weeks. It was made up of my own tumor tissue and dendritic cells. They’d create it just prior to my arrival. The first time they injected it in my arm and observe it a week later to see if I had any adverse reactions (I didn’t) and measure the skin response. The next 3 times were injected directly into the remaining tumor in my bladder via cystoscope. A few weeks after my bladder was removed I got another skin injection. The staff was really excited about the reaction of the skin around that injection because it was much bigger than the first one. It was my understanding that meant the vaccine had become systemic. So it could be a nice insurance policy if the study proves successful, otherwise it’s not going to hurt.
I’m not sure if the goal of the study is to find whether the vaccine disintegrates tumors by direct injection, or whether they are trying to prove it’s worth as a system vaccine. I just did what they told me to and I hope something good will come of it.
If you’re interested in knowing more, here’s a thumbnail description of the study and also a link to the article they gave me to read before I signed up that attempts to explain how it works. The article talks about vaccines for several types of cancer. The bladder cancer vaccine that utilizes dendritic cells that my doctor (Cheryl Lee) is leading is described about 3/4th of the way through the article:[b]Experimental Clinical Studies of the Direct Intratumoral Administration of Autologous Dendritic Cells (ADC) for the Treatment of Muscle Invasive Bladder Cancer prior to Cystectomy[/b][i]Objective is to determine whether autologous dendritic cell vaccine can be safely administered to patients with invasive bladder cancer and to determine the maximal tolerated dose of the vaccine. Secondary objective is to characterize the immune response to intratumoral autologous dendritic cell vaccination in bladder cancer patients. In this study scientists will monitor the research subjects for safety of the ADC vaccine as well as immune responses to the vaccine. Patients with invasive bladder cancer without metastasis (spread of cancer to other parts of the body) and are candidates for radical cystectomy (removal of the bladder) are eligible for this study. Sponsor is National Institute of Health and the American College of Surgeons. Principal Investigator is Cheryl T. Lee, MD. [/i]
Here’s the link: http://www.medicineatmichigan.org/magazine/2003/spring/cancer-vac/default.asp