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

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.

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