SU5416 in Treating Patients With AIDS-Related Kaposi's Sarcoma

Phase 1

Completed

• Conditions: Sarcoma

• Registration Number: NCT00003720
• Lead Sponsor: Pfizer

Brief Summary

RATIONALE: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have AIDS-related Kaposi's sarcoma.

Detailed Description

OBJECTIVES: I. Evaluate the safety and tolerability of SU5416 in patients with AIDS-related Kaposi's sarcoma. II. Determine the pharmacokinetics of this regimen in these patients. III. Evaluate the antitumor effects and biological activity of this regimen in these patients. IV. Determine the safety of this regimen on HIV replication and immune parameters in these patients.

OUTLINE: This is a dose escalation, multicenter study. Patients receive SU5416 by intravenous injection twice weekly for 4 weeks. Patients may continue treatment for a maximum of 1 year in the absence of disease progression and unacceptable toxicity. In the absence of dose limiting toxicity (DLT) in the first 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of SU5416 on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose (MTD). Six additional patients are treated at the MTD. Patients are followed at 30 days after the last treatment, and every 3 months thereafter.

PROJECTED ACCRUAL: This study will accrue a maximum of 30 patients.

Study Timeline

• Study Start: 1998-07
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-06-15
• Study First Posted: 2004-06-16
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-22
• Last Update Posted: 2012-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Kaplan Cancer Center; 🇺🇸 New York, New York, United States

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States

St. Francis Hospital; 🇺🇸 San Francisco, California, United States