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| Sponsor: | AIDS Associated Malignancies Clinical Trials Consortium |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052897 |
Purpose
RATIONALE: 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.
PURPOSE: 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anal Cancer |
Biological: HspE7 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Prevention |
| Official Title: | A Phase I/II Trial of SGN-00101 in the Treatment of High-Grade Anal Intraepithelial Neoplasia (AIN) in HIV-Positive Individuals |
| Study Start Date: | December 2002 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 5-18 patients will be accrued for this study within 1-6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed high-grade anal squamous intraepithelial lesions (HSIL) with residual HSIL of the anal canal or margin by high-resolution anoscopy
Documented evidence of HIV infection by one of the following methods:
Must have received stable highly active antiviral therapy (HAART) for at least 4 weeks before study
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent steroids that compromise immune function
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94143 | |
| Study Chair: | Joel Palefsky, MD | University of California, San Francisco |
More Information
| ClinicalTrials.gov Identifier: | NCT00052897 History of Changes |
| Other Study ID Numbers: | CDR0000258786, AMC-035 |
| Study First Received: | January 24, 2003 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
|
anal cancer |
|
Anus Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases |