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

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ClinicalTrials.gov Identifier: NCT00278434
Recruitment Status : Terminated (Accrual was insufficient to meet study endpoints)
First Posted : January 18, 2006
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

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 Type : Interventional  (Clinical Trial)
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 : April 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)



Primary Outcome Measures :
  1. Impact of Zoledronic Acid (ZA) on clinical response [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Study Chair: Karen Smith-McCune, MD, PhD University of California, San Francisco

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
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

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

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
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 in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs