Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278434
Status:
TERMINATED
Last Update Posted:
2017-11-24
First Post:
2006-01-16
Brief Title:
Zoledronate in Treating Patients With Cervical Intraepithelial Neoplasia 23 or 3
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
An Exploratory Clinical Trial of Zoledronic Acid in Women With CIN 23 or 3
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Accrual was insufficient to meet study endpoints
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 23 or 3
PURPOSE This randomized is studying how well zoledronate works in treating patients with cervical intraepithelial neoplasia 23 or 3
Detailed Description:
OBJECTIVES
Assess clinical response in terms of lesion size and histological grade of oledronate in patients with cervical intraepithelial neoplasia 23 or 3
OUTLINE This is a randomized placebo-controlled double-blind pilot study Patients are stratified according to degree of cervical intraepithelial neoplasia CIN CIN23 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
Assess clinical response in terms of lesion size and histological grade of oledronate in patients with cervical intraepithelial neoplasia 23 or 3
OUTLINE This is a randomized placebo-controlled double-blind pilot study Patients are stratified according to degree of cervical intraepithelial neoplasia CIN CIN23 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCSF-H7810-25693-02A | None | None | None |
| UCSF-03421 | None | None | None |
| UCSF-H7810-25693-01 | None | None | None |