CompletedPhase 1

Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma

United States24 participants

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria Concurrent Medication: AMENDED: * 04-21-91 Zidovudine (AZT) allowed after completing 8 weeks on the study. Patients on reduced doses of VP-16 must have tolerated at least 4 consecutive weeks at the reduced dose before starting AZT. Zidovudine will not be provided by the NIAID Clinical Product Research Repository. AMENDED: * Zidovudine (AZT) allowed after completing 12 weeks on study. Allowed: * Aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis (PCP). Concurrent Treatment: Allowed: * Local radiotherapy or laser therapy to cosmetically apparent, non-indicator lesions provided the dose to any one lesion does not exceed 300 rads and the total surface area of all lesions treated does not exceed 10 cm2. Risk Behavior: Allowed: * All risk groups. Patients must: * Have AIDS-related Kaposi's sarcoma. * Be ineligible for protocols of higher priority at study center. * Be willing to sign an informed consent or have guardian willing to sign. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Active opportunistic infection not specifically allowed. * Concurrent neoplasm not specifically allowed. * Significant neurologic, cardiac, or liver disease. Concurrent Medication: Excluded: * Therapy with potentially myelosuppressive, hepatotoxic, or nephrotoxic drugs for an opportunistic infection. Patients with the following are excluded: * Active opportunistic infection not sp…

Trial details

NCT IDNCT00000660

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL