RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients with cervical intraepithelial neoplasia. PURPOSE: This randomized phase II trial is studying how well SGN-00101 works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.
OBJECTIVES: * Compare the efficacy of SGN-00101 vs placebo in patients with grade II or III cervical intraepithelial neoplasia. * Correlate clinical response, as defined by histologic demonstration of lesion regression, with potential surrogate markers of vaccine efficacy (e.g., spectroscopic changes in the epithelium, development of human papilloma virus (HPV)-specific mucosal and systemic T-cell responses, and levels of HPV-specific antibody in cervical secretions), in patients treated with this drug. OUTLINE: This is a randomized, double-blind study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive SGN-00101 subcutaneously (SC) once a month for 3 consecutive months in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive placebo SC as in arm I. Patients are followed monthly for 3 months after the last injection and then undergo large loop excision of the transformation zone under colposcopy at the fourth month. Patients with disease progression undergo immediate large loop excision. PROJECTED ACCRUAL: A maximum of 80 patients (40 per treatment arm) will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Brigham and Women's Hospital
Boston, Massachusetts, United States
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