NCT00278434

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

An Exploratory Clinical Trial of Zoledronic Acid in Women With CIN 2/3 or 3

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Zoledronate
OTHER	Placebo (Saline)

Timeline

• Start date: 2005-04-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2006-01-18
• Last updated: 2017-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study