Zoledronate in Treating Patients With Cervical Intraepithelial Neoplasia 2/3 or 3
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278434
First received: January 16, 2006
Last updated: January 27, 2010
Last verified: July 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Condition |
Drug: zoledronic acid |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | An Exploratory Clinical Trial of Zoledronic Acid in Women With CIN 2/3 or 3 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Estimated Enrollment: | 44 |
| Study Start Date: | April 2005 |
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
University of California, San Francisco
Investigators
| Study Chair: | Karen Smith-McCune, MD, PhD | University of California, San Francisco |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00278434 History of Changes |
| Other Study ID Numbers: | CDR0000460044, UCSF-03421, UCSF-H7810-25693-01, UCSF-H7810-25693-02A |
| Study First Received: | January 16, 2006 |
| Last Updated: | January 27, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
cervical cancer cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3 |
Additional relevant MeSH terms:
|
Neoplasms Uterine Cervical Neoplasms Precancerous Conditions Cervical Intraepithelial Neoplasia Uterine Cervical Dysplasia Carcinoma in Situ Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases |
Uterine Diseases Genital Diseases, Female Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013