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

University of California San Francisco (UCSF)

Status and phase: Terminated; Phase 1

Conditions: Precancerous Condition; Cervical Cancer

Treatments: Drug: Zoledronate; Other: Placebo (Saline)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00278434

UCSF-H7810-25693-01

CDR0000460044

UCSF-03421

UCSF-H7810-25693-02A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Zoledronate

Experimental group

Description:

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.

Treatment:

Drug: Zoledronate

Saline

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo (Saline)