Clinical trial NCT00278434: Zoledronate in Treating Patients With Cervical Intraepithelial Neoplasia 2/3 or 3
Official title: An Exploratory Clinical Trial of Zoledronic Acid in Women With CIN 2/3 or 3
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cervical Cancer
Precancerous Condition
Keywords: cervical cancer
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-01-18
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Impact of Zoledronic Acid (ZA) on clinical response
timeFrame: 10 weeks from start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Karen Smith-McCune, MD, PhD
role: STUDY_CHAIR
References: