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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00278434
• Other study ID #: CDR0000460044
• Secondary ID: UCSF-03421UCSF-H
• Status: Terminated
• Phase: Phase 1
• First received: January 16, 2006
• Last updated: November 21, 2017
• Start date: April 2005
• Est. completion date: July 2008

Study information

• Verified date: November 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Precancerous Condition
• Precancerous Conditions
• Uterine Cervical Neoplasms

Intervention

Drug:
• Zoledronate

Other:
• Placebo (Saline)

Locations

Country	Name	City	State
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of Zoledronic Acid (ZA) on clinical response	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).	10 weeks from start of treatment