NCT00278434

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

3.3 years

First QC Date

January 16, 2006

Last Update Submit

November 21, 2017

Conditions

Cervical CancerPrecancerous Condition

Keywords

cervical cancercervical intraepithelial neoplasia grade 2cervical intraepithelial neoplasia grade 3

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Zoledronate

EXPERIMENTAL

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

Saline

PLACEBO COMPARATOR

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)

Interventions

ZoledronateDRUG
Zoledronate
Placebo (Saline)OTHER
Saline

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPrecancerous ConditionsUterine Cervical Dysplasia

Interventions

Zoledronic AcidSodium Chloride

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Karen Smith-McCune, MD, PhD

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2006

First Posted

January 18, 2006

Study Start

April 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

November 24, 2017

Record last verified: 2017-11

Locations

US(1)