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

Primary Purpose

Cervical Cancer, Precancerous Condition

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Zoledronate
Placebo (Saline)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept 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 PRIOR CONCURRENT THERAPY: No concurrent loop diuretics, aminoglycosides, other nephrotoxic drugs, immunosuppressive drugs, or other investigational agents

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zoledronate

Saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
January 16, 2006
Last Updated
November 21, 2017
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00278434
Brief Title
Zoledronate in Treating Patients With Cervical Intraepithelial Neoplasia 2/3 or 3
Official Title
An Exploratory Clinical Trial of Zoledronic Acid in Women With CIN 2/3 or 3
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Accrual was insufficient to meet study endpoints
Study Start Date
April 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Precancerous Condition
Keywords
cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zoledronate
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Zoledronate
Intervention Type
Other
Intervention Name(s)
Placebo (Saline)
Primary Outcome Measure Information:
Title
Impact of Zoledronic Acid (ZA) on clinical response
Description
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).
Time Frame
10 weeks from start of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Smith-McCune, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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

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