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

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.