Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma
Status:
Completed
Trial end date:
1992-07-01
Target enrollment:
Participant gender:
Summary
To define the toxicity and maximum-tolerated dose of weekly oral etoposide (VP-16) in
patients with AIDS-related Kaposi's sarcoma; to determine the clinical pharmacology of orally
administered VP-16 in AIDS patients. A secondary objective is to obtain preliminary data for
determining the effect of oral VP-16 on Kaposi's sarcoma.
VP-16 is an antitumor agent. Previous problems with VP-16 include the route of administration
and the toxicities. VP-16 has been given intravenously for 3 consecutive days in a 21-day
cycle for lung cancer and testicular cancer. VP-16 has also been used in lymphoma therapy.
Oral VP-16 would eliminate the need for an intravenous catheter and so a patient could avoid
the pain, inconvenience, and potential complications associated with medications administered
intravenously. The relative ease of outpatient administration and the potentially significant
antitumor activity of oral VP-16 motivates this study. The possibility of weekly drug
administration is the other focus of this study.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)