Patients who exhibit residual or progressive disease following 6 courses of chemotherapy receive IL-12 biweekly for 24 weeks. Previously treated patients receive IL-12 biweekly, beginning at least 21 days following the last course of chemotherapy. Phase Phase II A phase two trial follows phase one. It consists of a larger, randomized sample of patients. The purpose of a phase two trial is to see if the drug is effective at doing what the manufacturer claims it should do.
Researchers also watch closely for unexpected adverse reactions.
25 previously treated patients. Unless due to tumor involvement in patients to be treated with chemotherapy. Concurrent antiretroviral therapy at the discretion of the principal investigator. History of clinical heart failure. History of inflammatory bowel disease.