• Complete histologic regression [ Designated as safety issue: No ]
• Frequency and severity of adverse events [ Designated as safety issue: Yes ]

• Complete histologic regression
• Frequency and severity of adverse events

RATIONALE: Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia.

OBJECTIVES:

Primary

• Determine the efficacy of SGN-00101, in terms of complete histologic regression, in patients with grade III cervical intraepithelial neoplasia.
• Determine the toxicity of this drug in these patients.

Secondary

• Determine change in lesion size in these patients after treatment with this drug.
• Compare histologic response before and after treatment with this drug in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression.
• Arm II: Patients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.

Patients are followed at 19 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 28-84 patients (14-42 per treatment arm) will be accrued for this study within 12-48 months.

• Cervical Cancer
• Precancerous/Nonmalignant Condition

DISEASE CHARACTERISTICS:

• Histologically confirmed grade III cervical intraepithelial neoplasia

  • Confirmed by biopsy or colposcopy
• Positive for human papilloma virus 16
• No endocervical glandular dysplasia
• No adenocarcinoma in situ

PATIENT CHARACTERISTICS:

Age

• 17 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• No life-threatening or serious hematological disorder

Hepatic

• No life-threatening or serious hepatic disorder

Renal

• No life-threatening or serious renal disorder

Cardiovascular

• No life-threatening or serious cardiac disorder

Pulmonary

• No life-threatening or serious respiratory disorder

Immunologic

• HIV negative
• Must be immunocompetent
• No history of autoimmune disease
• No life-threatening or serious immunological disorder
• No prior or concurrent severe allergic disease
• No concurrent human papilloma viral infection other than type 16

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No life-threatening or serious gastrointestinal disorder
• No life-threatening or serious endocrine disorder
• No invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• No concurrent chronic or systemic steroids

Radiotherapy

• Not specified

Surgery

• No prior organ transplantation

Other

• No prior cancer therapy that would preclude study therapy