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

Completed · Phase 1

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000660

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

24

Expected to finish

1992-07-01

Last updated by the study team

2021-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• San Francisco Gen Hosp — San Francisco, California, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Mem Sloan - Kettering Cancer Ctr — New York, New York, United States
• Saint Luke's - Roosevelt Hosp Ctr — New York, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• Julio Arroyo — West Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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