Cervical Cancer, Precancerous Condition
Conditions
Keywords
cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3
Brief summary
RATIONALE: Chemoprevention is the use of certain drugs to keep tumors from forming, growing, or coming back. Zoledronate may prevent the growth of cervical cancer by blocking blood flow to cervical intraepithelial neoplasia cells. The use of zoledronate may keep cancer from forming. PURPOSE: This randomized is studying how well zoledronate works in treating patients with cervical intraepithelial neoplasia 2/3 or 3.
Detailed description
OBJECTIVES: * Assess clinical response, in terms of lesion size and histological grade, of oledronate 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. * Zoledronate: 100 cc of saline with 4 mg of Zoledronate intravenous (IV), over 20 minutes, for 3 doses one week apart * Placebo: 100 cc of saline (IV), over 20 minutes, for 3 doses one week apart 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.
Interventions
DRUGZoledronate
OTHERPlacebo (Saline)
Sponsors
National Cancer Institute (NCI)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Zoledronic Acid (ZA) on clinical response | 10 weeks from start of treatment | The primary objective is to determine whether Zoledronic Acid (ZA), when given to women with CIN 2/3 or 3 for two months prior to surgical excision, has a measurable impact on clinical response (lesion size and histological grade). |
Countries
United States
Outcome results
None listed