Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma

SUGEN30 enrolled

Overview

The purpose of this study is to see if it is safe and effective to give SU5416 to HIV-infected patients with AIDS-related Kaposi's sarcoma (KS). SU5416 may prevent the growth of KS tumors.

Groups of 3-6 patients are sequentially assigned to receive escalating doses of SU5416 in 33% increments. Study drug is administered as a twice-weekly intravenous injection for 4 weeks. In the absence of unacceptable toxicity, responding patients may continue on SU5416 in 4-week treatment cycles for a maximum of 1 year or until the presence of unacceptable toxicity or tumor progression.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Sarcoma, Kaposi HIV Infections

Interventions

SU5416DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria You may be eligible for this study if you: * Are at least 18 years old. * Are HIV-positive. * Have KS with at least 5 skin lesions. * Have been in stable condition for at least 6 weeks prior to study entry, if receiving antiretroviral therapy. * Agree to use effective methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: * Have had surgery within 4 weeks of study entry. * Have taken certain medications, including therapy for KS, within 3 weeks prior to study entry. * Have pulmonary KS (KS in your lungs). * Have certain serious medical conditions, including liver or kidney problems, certain infections, and certain cancers. * Are allergic to Cremophor. * Have not recovered from previous cancer treatment (chemotherapy, radiotherapy, or immunotherapy). * Are pregnant.

Locations (4)

Norris Cancer Ctr / USC

Los Angeles, California, United States

UCLA Care Ctr / Ctr for Hlth Sciences

Los Angeles, California, United States

Saint Francis Mem Hosp / HIV Care Unit

San Francisco, California, United States

New York Univ Med Ctr

New York, New York, United States

Data from ClinicalTrials.gov

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