Laheru's Vaccine Trial

After Christmas, we set to work trying to get my mother enrolled in Laheru's GVAX vaccine trial. Hopkins now has a trial for patients who have finished their chemotherapy regimen by at least one month. This is another phase II trial that will accept up to 60 patients. The coordinator mentioned that they expect it to close around the summer time.

Laheru just released updated results from the first phase II trial for the vaccine. About 60 patients at Hopkins were given the vaccine shortly after surgery and concurrently with chemotherapy. The 2 year results that were released a few years ago seemed very promising. The updated results don't follow the same stellar trend but they still seem to show significantly better results than just standard treatment alone: 26 months vs. 18 months median survival.

To enroll in the trial, you need to have a clean CT scan and your blood test numbers need to be relatively normal. The first time we tried, our mother's neutrophil count was too low. The next week that we tried, her liver AAT count was abnormally high - around 300. My mother had been taking the antibiotic Ciprofloxacin which was prescribed in November because of her chronic fevers. The Cipro worked wonders on her fever, so she was advised to continue taking it for several months. It turns out that Cipro might be harmful on your liver. She stopped taking it and 2 weeks later her liver counts were normal again. So we finally were able to get into the study.

The study involves getting a series of injections of the GVAX vaccine. The injections are given monthly for 3 months and then every 6 months. The first treatment involves getting 6 injections of GVAX, a tetanus shot and having a skin biopsy done. For the first week, you need to go in every day for bloodwork. My mother had her first treatment yesterday. The side effects have been fairly mild - just some swelling on the injection sites and she seems somewhat tired. Nothing like chemotherapy.