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

NCT00052897 | Completed Phase 1

• 3 other identifiers: NCI-2012-02507AMC-035CDR0000258786
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Cancer

Keywords

anal cancer

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Biological: HspE7

Interventions

HspE7 BIOLOGICAL

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed high-grade anal squamous intraepithelial lesions (HSIL) with residual HSIL of the anal canal or margin by high-resolution anoscopy * Declined routine surgery or not a candidate for surgical excision of HSIL * Documented evidence of HIV infection by one of the following methods: * Serologic (ELISA or western blot) * Culture * Quantitative polymerase chain reaction or bDNA assays * HIV RNA no greater than 500 copies/mL * CD4 at least 200 x 10\^6/L * Must have received stable highly active antiviral therapy (HAART) for at least 4 weeks before study * HAART defined as 3 or more agents, including a protease inhibitor or nonnucleoside reverse transcriptase inhibitor that is approved or available through expanded access combination antiviral therapy * No prior history of invasive anal or cervical cancer * No concurrent untreated cervical HSIL PATIENT CHARACTERISTICS: Age * 18 and over Life expectancy * At least 12 months Hematopoietic * Hemoglobin at least 10 g/dL * Platelet count at least 75,000/mm\^3 * Absolute neutrophil count at least 1,000/mm\^3 Hepatic * AST and ALT no greater than 3 times upper limit of normal (ULN) Renal * Creatinine no greater than 1.5 times ULN Immunologic * No prior severe allergic reactions (i.e., anaphylactic response) to drugs or any other allergen * No history of collagen-vascular or autoimmune disorder requiring treatment within the past 5 years * No other concurrent illness that compromises the immune system * No active serious opportunistic infection Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 forms of effective contraception during and for 3 months after study * No concurrent participation in a conception process (e.g., active attempt to become pregnant or impregnate, sperm donation, or in vitro fertilization) * No other concurrent medical or psychiatric illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunostimulants (including interferon or interleukin-12) Chemotherapy * More than 1 year since prior chemotherapy for cancer Endocrine therapy * No concurrent steroids that compromise immune function * Concurrent topical corticosteroids allowed if dose determined not to suppress immune function Radiotherapy * More than 1 year since prior radiotherapy for cancer Other * More than 30 days since other prior investigational agents * No concurrent medications that suppress immune function

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

UCSF Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Joel Palefsky, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2003
• First Posted: January 27, 2003
• Study Start: December 1, 2002
• Primary Completion: July 1, 2005
• Last Updated: February 11, 2013

Record last verified: 2004-04

Locations

US (1)