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


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer, Precancerous Condition

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Trial Information

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


OBJECTIVES:

- Assess clinical response, in terms of lesion size and histological grade, of
zoledronate 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.

- Arm I: Patients receive zoledronate IV over 20 minutes on day 1.

- Arm II: Patients receive placebo IV over 20 minutes on day 1. 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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Karen Smith-McCune, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

Unspecified

Study ID:

CDR0000460044

NCT ID:

NCT00278434

Start Date:

April 2005

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • cervical cancer
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia
  • Uterine Cervical Dysplasia
  • Carcinoma in Situ

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115