Robert is scheduled to begin the GVAX trial at Johns Hopkins next week. If you want to know what it’s all about, and/or why we decided to go this route, this post will explain.
First a refresher – this trial is being done to test an experimental vaccine that is intended to boost the body’s immune system to fight melanoma. Although we know that there are no active cancer cells growing in his body, we don’t know whether there are tiny, inactive cells (micro-metastases) lurking in there somewhere that might decide to become active at some point in the future. If there are, we hope this vaccine will stimulate an immune reaction in his body to kill them.
Robert is at high risk for recurrence of his melanoma because this was a very deep lesion – 9.5mm. That means that it extended down into the dermis, close to where microscopic cancer cells could enter the lymphatic system and might be transported to other parts of his body. So, while it would be nice to think that all the cancer was removed, as the biopsies indicated, our doctors don’t think it’s prudent to count on that. Therefore, they have recommended that he participate in this trial so that he can get the vaccine.
The trial’s purpose is study the safety of the vaccine at different doses. The first study group received a low dosage of the vaccine, and when no serious adverse reactions were found, the second group began to receive higher doses. Robert is in this second group.
The vaccine will be administered four times, at 28-day intervals, beginning on November 6. Each month, the correct amount of vaccine for Robert’s body weight will be injected at six sites on his arms and thighs. One to two hours beforehand, a skin-numbing medicine will be applied to each vaccine site. After the injections, we will wait about a half hour to see if there is a reaction. As long as there’s no bad reaction, he will be discharged.
Two weeks after each vaccination, Robert will call our study nurse, Susan, to report on any side effects he has had from the vaccine. Common side effects are redness, swelling, itching, and/or soreness at the vaccine sites. Less-common side effects are flu-like symptoms, including fatigue, rashes, low-grade fever, and chills, as well as swollen lymph nodes and flare-ups at the injection sites. Susan told us that so far none of the study participants have had more serious side effects.
After the first and fourth injections, we will return to Johns Hopkins two days later for a biopsy of one of the vaccination sites. The biopsy sample will be studied in a research laboratory and/or by a pathologist to look for effects from the vaccine.
One month after the final vaccine, in late February, Robert will have a check-up including blood work. The final visit will be April 23, when he will have the six-month CT scan of his chest, abdomen, and pelvis and a brain MRI in addition to the physical exam and blood work. I guess that makes April 23 my next, highly anticipated date with N.E.D. ...
The Food and Drug Administration considers this GVAX vaccine to be a kind of “gene therapy,” and the FDA wants all patients receiving gene therapy to undergo five years of follow-up, looking for “late side effects.” These annual visits will include physical exams, blood tests, and scans. If possible, we will have the follow-up care with Dr. Lipson here in D.C. at Sibley Hospital, which Hopkins has acquired recently. Dr. Lipson will be starting up a research program at Sibley, which is just a few miles from our house.
So – that’s the scoop! Questions? Feel free to call.