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

Sponsor

University of California, San Francisco (Other)

Overall Status

Terminated

CT.gov ID

NCT00278434

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Precancerous Condition	Drug: Zoledronate Other: Placebo (Saline)	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zoledronate 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
Placebo Comparator: Saline 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)

Arm

Intervention/Treatment

Experimental: Zoledronate

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

Placebo Comparator: Saline

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)

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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