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

You may be eligible if

• 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