Interleukin-12 in Treating Patients With AIDS-Related Kaposi's Sarcoma

Phase 1

Completed

• Conditions: Epidemic Kaposi's Sarcoma; Recurrent Kaposi's Sarcoma

• Registration Number: NCT00019188
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill their tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of interleukin-12 in treating patients with AIDS -related Kaposi's sarcoma.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of interleukin-12 (IL-12) in patients with AIDS-associated Kaposi's sarcoma.

II. Determine the antitumor activity of IL-12 in these patients. III. Determine the effect of IL-12 on angiogenic factors, including basic fibroblast growth factor, vascular endothelial growth factor, and interferon-inducible protein 10 in these patients.

IV. Determine the immunologic and virologic effects of IL-12 in these patients.

PROTOCOL OUTLINE: This is a dose escalation study. Patients receive interleukin-12 (IL-12) subcutaneously twice a week (at least 3 days apart) for 6 months. Patients with stable or better disease continue IL-12 treatment in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Ten additional patients are treated at the MTD.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL:

Up to 55 patients will be entered over approximately 4.0 years.

Study Timeline

• Study Start: 1997-01
• Study Completion: 2007-03
• Study First Submitted: 2007-03-01
• Study First Submitted QC: 2007-03-01
• Study First Posted: 2007-03-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04

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 (1)

Medicine Branch; 🇺🇸 Bethesda, Maryland, United States