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

Phase 1

Completed

• Conditions: Anal Cancer
• Interventions: Biological: HspE7

• Registration Number: NCT00052897
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2003-01-24
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2004-04
• Primary Completion: 2005-07
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	HspE7	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.

Trial Locations

Locations (1)

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States