An Exploratory Clinical Trial of Zoledronic Acid in Women With CIN 2/3 or 3
- Assess clinical response, in terms of lesion size and histological grade, of
zoledronate in patients with cervical intraepithelial neoplasia 2/3 or 3.
OUTLINE: This is a randomized, placebo-controlled, double-blind, pilot study. Patients are
stratified according to degree of cervical intraepithelial neoplasia (CIN) (CIN2/3 vs CIN3).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive zoledronate IV over 20 minutes on day 1.
- Arm II: Patients receive placebo IV over 20 minutes on day 1. In both arms, treatment
repeats every 21 days for up to 3 courses. In week 8, patients undergo surgical
resection comprising loop excision or cone biopsy.
After completion of study treatment, patients are followed at week 10 by telephone.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Karen Smith-McCune, MD, PhD
University of California, San Francisco
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|