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

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), July 2007

First Received: January 16, 2006 Last Updated: September 4, 2008 History of Changes

Sponsors and Collaborators:	UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00278434

Purpose

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	Intervention
Cervical Cancer Precancerous/Nonmalignant Condition	Drug: zoledronic acid

MedlinePlus related topics: Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	An Exploratory Clinical Trial of Zoledronic Acid in Women With CIN 2/3 or 3

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	44
Study Start Date:	April 2005

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278434

Locations

United States, California
UCSF Helen Diller Family Comprehensive Cancer Center	Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222

Sponsors and Collaborators

UCSF Helen Diller Family Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Karen Smith-McCune, MD, PhD

UCSF Helen Diller Family Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000460044, UCSF-03421, UCSF-H7810-25693-01, UCSF-H7810-25693-02A
Study First Received:	January 16, 2006
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00278434 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

cervical cancer
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Study placed in the following topic categories:

Zoledronic acid
Precancerous Conditions
Carcinoma in Situ
Bone Density Conservation Agents

Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Neoplasms
Zoledronic acid
Neoplasms by Histologic Type
Precancerous Conditions
Carcinoma in Situ
Physiological Effects of Drugs

Bone Density Conservation Agents
Pharmacologic Actions
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

ClinicalTrials.gov processed this record on May 07, 2009