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

Sugen

Status: Completed

Conditions: Sarcoma, Kaposi; HIV Infections

Treatments: Drug: SU5416

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002226

5416.003

294A

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.