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

Inclusion Criteria

• •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