Clinical Trial in the Spotlight

Date: June 1, 2004

Clinical vaccine for chronic leukemia being studied

Johns Hopkins Kimmel Cancer Center researchers are testing a vaccine to recruit the immune system in fighting chronic myeloid leukemia (CML). The Phase I/II study will test the vaccine in 20 patients who have been taking the anticancer drug Gleevec for one year but may still have detectable disease in their blood.

Follow-up data show that the disease comes back in many leukemia patients taking Gleevec, an oral drug that interferes with the cellular pathways that signal tumor cell growth, and most patients still have leukemia cells circulating in their blood. These patients may appear healthy, but could relapse with time.

Researchers will monitor patients for three months and if leukemic cells are detected, administer four doses of vaccine over nine weeks. The vaccinated patients will be monitored for another 36 weeks.

The vaccine uses lab-grown irradiated chronic myeloid leukemia cells genetically modified with the immune-boosting gene GM-CSF. Immune cells are attracted to the vaccine and recognize its antigens, which serve as red flags that cause the immune system to seek out and destroy cancer cells elsewhere in the body. n For more information, contact:

Hyam Levitsky, M.D. 410-614-0552

Karen Friel 410-502-7114.