NCT00052897

SGN-00101 in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia

A Phase I/II Trial of SGN-00101 in the Treatment of High-Grade Anal Intraepithelial Neoplasia (AIN) in HIV-Positive Individuals

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase I/II trial to study the effectiveness of SGN-00101 in preventing anal cancer in HIV-positive patients who have high-grade anal neoplasia. Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. SGN-00101 may be effective in preventing anal cancer.

Detailed description

OBJECTIVES: I. Determine the safety and maximum tolerated dose of SGN-00101 in HIV-positive patients with high-grade anal squamous intraepithelial lesions. II. Determine clinical response and histologic/cytologic regression in patients treated with this drug. III. Determine immune response in patients treated with this drug. IV. Determine the effect of this drug on HIV viral load and CD4 level in these patients. OUTLINE: This is a dose-escalation study. Patients receive SGN-00101 subcutaneously once on weeks 0, 4, and 8. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 5-6 patients receive escalating doses of SGN-00101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity. Patients are followed at 1, 4, and 10 months.

Conditions

• Anal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	HspE7

Timeline

• Start date: 2002-12-01
• Primary completion: 2005-07-01
• First posted: 2003-01-27
• Last updated: 2013-02-11

Locations

1 site across 1 country: United States