Status:
TERMINATED
Zoledronate in Treating Patients With Cervical Intraepithelial Neoplasia 2/3 or 3
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
Precancerous Condition
Eligibility:
FEMALE
18-120 years
Phase:
PHASE1
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 in...
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, pla...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00278434
Start Date
April 1 2005
End Date
July 1 2008
Last Update
November 24 2017
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115