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