Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003075
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
1999-11-01
Brief Title:
Fenretinide in Treating Patients With Cervical Neoplasia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Randomized Double-Blind Study of N-4-hydroxyphenyl Retinamide 4-HPR Versus Placebo in Patients With Cervical Intraepithelial Neoplasia CIN Grade 2-3
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention uses drugs to try and prevent development of cancer Fenretinide may be effective in treating cervical neoplasia and preventing cervical cancer
PURPOSE Randomized double-blinded phase III trial to compare the effectiveness of fenretinide to placebo in treating patients with cervical neoplasia
PURPOSE Randomized double-blinded phase III trial to compare the effectiveness of fenretinide to placebo in treating patients with cervical neoplasia
Detailed Description:
OBJECTIVES I Determine the efficacy of fenretinide N-4-hydroxyphenyl retinamide 4-HPR at regressing cervical intraepithelial neoplasia CIN II Document the qualitative and quantitative toxicity of 4-HPR in women with CIN
OUTLINE This is a double blinded study Patients are randomized to receive either fenretinide or placebo Patients are administered fenretinide or a placebo by mouth PO daily for 6 months with 3 days of rest every month Patients undergo colposcopy colpophotography and Pap smears at 3 6 9 and 12 months Patients undergo cervical biopsy at 6 and 12 months to assess changes
PROJECTED ACCRUAL 84-100 patients will be accrued
OUTLINE This is a double blinded study Patients are randomized to receive either fenretinide or placebo Patients are administered fenretinide or a placebo by mouth PO daily for 6 months with 3 days of rest every month Patients undergo colposcopy colpophotography and Pap smears at 3 6 9 and 12 months Patients undergo cervical biopsy at 6 and 12 months to assess changes
PROJECTED ACCRUAL 84-100 patients will be accrued
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| MDA-ID-92027 | OTHER | None | None |
| NCI-P97-0092 | None | None | None |
| CDR0000065761 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |