A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma

Phase 1

Completed

• Conditions: Sarcoma, Kaposi; HIV Infections

• Registration Number: NCT00000763
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To assess toxicity and determine the MTD of intravenous TNP-470 administered weekly in patients with AIDS-related Kaposi's sarcoma. To assess pharmacokinetics and tumor response of the drug.

Since evidence shows that neovascularization is important in the development of Kaposi's sarcoma, drugs that inhibit angiogenesis, such as TNP-470, may be of benefit in patients with the disease.

Detailed Description

Since evidence shows that neovascularization is important in the development of Kaposi's sarcoma, drugs that inhibit angiogenesis, such as TNP-470, may be of benefit in patients with the disease.

Patients are entered at 7 escalating dose levels of TNP-470. (PER AMENDMENT 9/3/96: dose maximum level changed.) Four patients treated at a given dose level must receive at least 4 weeks of therapy before escalation in subsequent cohorts proceeds. If 50 percent of patients at a given dose level experience dose-limiting toxicity, the previous dose is defined as the MTD and an additional two patients are treated at the MTD. Patients receive treatment for 12 weeks, followed by 2 weeks of rest, followed by an additional 12 weeks of treatment. Patients are followed for 12 weeks post-treatment.

Study Timeline

• Study Completion: 1997-02
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

Northwestern University CRS; 🇺🇸 Chicago, Illinois, United States

Bmc Actg Crs; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess - East Campus A0102 CRS; 🇺🇸 Boston, Massachusetts, United States

Washington U CRS; 🇺🇸 Saint Louis, Missouri, United States

USC CRS; 🇺🇸 Los Angeles, California, United States

Beth Israel Med. Ctr. (Mt. Sinai); 🇺🇸 New York, New York, United States