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

This study has been terminated.
(Accrual was insufficient to meet study endpoints)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00278434
First received: January 16, 2006
Last updated: August 2, 2013
Last verified: August 2013
  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 Phase
Cervical Cancer
Precancerous Condition
Drug: zoledronic acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 University of California, San Francisco:

Enrollment: 12
Study Start Date: April 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: zoledronate IV Drug: zoledronic acid
Placebo Comparator: placebo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Chair: Karen Smith-McCune, MD, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
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: August 2, 2013
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of California, San Francisco:
cervical cancer
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014