A Phase I/II Trial of SGN-00101 in the Treatment of High-Grade Anal Intraepithelial Neoplasia (AIN) in HIV-Positive Individuals

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