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

HIV Infections Clinical Trial

Official title:

A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002226
• Other study ID #: 294A
• Secondary ID: 5416.003
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• SU5416

Locations

Country	Name	City	State
United States	Norris Cancer Ctr / USC	Los Angeles	California
United States	UCLA Care Ctr / Ctr for Hlth Sciences	Los Angeles	California
United States	New York Univ Med Ctr	New York	New York
United States	Saint Francis Mem Hosp / HIV Care Unit	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
SUGEN

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gill P, Arasteh K, Jacobs M, Friedman-Kiel A, Miles S, Gracey S, Hannah A, Langecker P. A multicenter, dose-escalating study in patients with AIDS-related Kaposi's Sarcoma 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29