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

NCT ID: NCT00278434

Last Updated: 2017-11-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2008-07-31

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.

Conditions

Cervical Cancer; Precancerous Condition

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Zoledronate

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo (Saline)

Intervention Type: OTHER

Interventions

Zoledronate

Intervention Type: DRUG

Placebo (Saline)

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Smith-McCune, MD, PhD

Role: STUDY_CHAIR

University of California, San Francisco

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Countries

United States

Other Identifiers

UCSF-03421

Identifier Type: -

Identifier Source: secondary_id

UCSF-H7810-25693-01

Identifier Type: -

Identifier Source: secondary_id

UCSF-H7810-25693-02A

Identifier Type: -

Identifier Source: secondary_id

CDR0000460044

Identifier Type: -

Identifier Source: org_study_id