Zoledronate in Treating Patients With Cervical Intraepithelial Neoplasia 2/3 or 3

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Exploratory Clinical Trial of Zoledronic Acid in Women With CIN 2/3 or 3

Conditions
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Cervical Cancer, Precancerous Condition

Intervention / Treatment
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* Drug: Zoledronate
* Other: Placebo (Saline)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zoledronate<br>100 cc of saline with 4 mg of zoledronate intravenous (IV), over 20 minutes, for 3 doses one week apart Treatment repeats every 21 days (one course) 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. | Drug: Zoledronate<br> <br> |
| Placebo Comparator: Saline<br>100 cc of saline IV, over 20 minutes, for 3 doses one week apart Treatment repeats every 21 days (one course) 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. | Other: Placebo (Saline)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Zoledronic Acid (ZA) on clinical response | 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). | 10 weeks from start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3