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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 motivate...

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Eligibility criteria

• • 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 specifically allowed.
• • Ongoing therapy, including maintenance therapy, for an opportunistic infection with potentially myelosuppressive, hepatotoxic, or nephrotoxic drugs.
• • Concurrent neoplasm not specifically allowed.
• • Significant neurologic, cardiac, or liver disease.
• Prior Medication:
• Excluded:
• • Biologic response modifiers or corticosteroids within 14 days prior to study entry.
• • Cytotoxic chemotherapy within 30 days prior to study entry.
• • Ribavirin within 6 weeks prior to study entry.
• • Azidothymidine (AZT), alpha-interferon, didanosine (ddI), ganciclovir (DHPG), or any other antiretroviral drugs within 1 week prior to study entry.
• Prior Treatment:
• Excluded within 30 days prior to study entry:
• • Radiation therapy with \> 4000 rads.
• • Total skin electron beam therapy.