Phase II Randomized, Double-Blinded Trial Of SGN-00101 (HSP-E7) For Treatment Of CIN II/III
- Compare the efficacy of SGN-00101 vs placebo in patients with grade II or III cervical
- 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
- 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
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Kristin A. Keefe, MD
Dana-Farber/Brigham and Women's Cancer Center
United States: Federal Government
|Brigham and Women's Hospital||Boston, Massachusetts 02115|