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

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