An Exploratory Clinical Trial of Zoledronic Acid in Women With CIN 2/3 or 3
18 Years
N/A
Female
Cervical Cancer, Precancerous Condition
Trial Information
An Exploratory Clinical Trial of Zoledronic Acid in Women With CIN 2/3 or 3
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Biopsy confirmed cervical intraepithelial neoplasia (CIN) 2/3 or 3
- Planning loop excision or cone biopsy
- Diagnosis within 2 months prior to study entry
- Standard histological grading according to Richart
- Visible lesion by colposcopy
- No unsatisfactory colposcopy or lesions extending into the endocervical canal
that cannot be visualized entirely by colposcopy
- No suspicion of invasive cervical cancer by cytology, histology or colposcopy
- No cytologic evidence of glandular atypia or dysplasia
PATIENT CHARACTERISTICS:
- Creatinine normal
- Screening laboratory values within normal range (e.g., complete blood count, liver
function tests, renal panel, and electrolytes)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to read and speak English or Spanish
- No known hypersensitivity to bisphosphonates
- Not immunocompromised
- No known HIV positivity
- No aspirin-sensitive asthma due to association of bisphosphonates with
bronchoconstriction
- No unexplained abnormal vaginal bleeding
PRIOR CONCURRENT THERAPY:
- No concurrent loop diuretics, aminoglycosides, other nephrotoxic drugs,
immunosuppressive drugs, or other investigational agents
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Principal Investigator
Karen Smith-McCune, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, San Francisco
Authority:
Unspecified
Study ID:
CDR0000460044
NCT ID:
NCT00278434
Start Date:
April 2005
Completion Date:
Related Keywords:
- Cervical Cancer
- Precancerous Condition
- cervical cancer
- cervical intraepithelial neoplasia grade 2
- cervical intraepithelial neoplasia grade 3
- Neoplasms
- Uterine Cervical Neoplasms
- Precancerous Conditions
- Cervical Intraepithelial Neoplasia
- Uterine Cervical Dysplasia
- Carcinoma in Situ
Name | Location |
|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
