Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003223
Status:
TERMINATED
Last Update Posted:
2012-07-24
First Post:
1999-11-01
Brief Title:
SWOG-9507 Fenretinide in Treating Patients With Neoplasia of the Mouth
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Single Arm Phase II Study to Determine the Safety and Efficacy of 4-HPRN-4-Hydroxyphenyl Retinamide for Treating Oral Intraepithelial Neoplasia
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of fenretinide may be an effective way to prevent the development of cancer in patients with neoplasia of the mouth
PURPOSE Phase II trial to study the effectiveness of fenretinide in preventing cancer in patients who have neoplasia of the mouth
PURPOSE Phase II trial to study the effectiveness of fenretinide in preventing cancer in patients who have neoplasia of the mouth
Detailed Description:
OBJECTIVES I Evaluate the efficacy of fenretinide in patients with oral intraepithelial neoplasia II Assess the toxicity of fenretinide in these patients
OUTLINE Patients receive oral fenretinide on days 1-25 every 28 days for a maximum of 6 courses After 6 courses patients receive a post-treatment biopsy Patients exhibiting disease progression or unacceptable toxicities are removed from the study Patients are followed at 3 and 6 months
PROJECTED ACCRUAL A total of 51 patients will be accrued
OUTLINE Patients receive oral fenretinide on days 1-25 every 28 days for a maximum of 6 courses After 6 courses patients receive a post-treatment biopsy Patients exhibiting disease progression or unacceptable toxicities are removed from the study Patients are followed at 3 and 6 months
PROJECTED ACCRUAL A total of 51 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 |
|---|---|---|---|
| U10CA037429 | NIH | SWOG | httpsreporternihgovquickSearchU10CA037429 |
| SWOG-9507 | OTHER | None | None |