Patients have clinic visits at least twice a month. Patients with a complete or partial response may continue treatment until disease progression intervenes. 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.
Biopsy-proven KS with at least 5 measurable lesions. Lesions must be evaluable by noninvasive methods. Life expectancy of more than 3 months. NCI pathology review. For patients with HIV infection only.