Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006471
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2000-11-06
Brief Title:
Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Fenretinide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent or metastatic head and neck cancer
PURPOSE Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent or metastatic head and neck cancer
Detailed Description:
OBJECTIVES
Determine the response rate time to progression median survival and percent of 1-year survival in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with fenretinide
Determine the pharmacokinetics and safety of this drug in these patients
OUTLINE Patients receive oral fenretinide every 12 hours on days 1-7 Treatment repeats every 3 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete response continue treatment for 1 year
PROJECTED ACCRUAL A total of 16-35 patients will be accrued for this study
Determine the response rate time to progression median survival and percent of 1-year survival in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with fenretinide
Determine the pharmacokinetics and safety of this drug in these patients
OUTLINE Patients receive oral fenretinide every 12 hours on days 1-7 Treatment repeats every 3 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete response continue treatment for 1 year
PROJECTED ACCRUAL A total of 16-35 patients will be accrued for this study
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 |
|---|---|---|---|
| U01CA070172 | NIH | None | None |
| P30CA016672 | NIH | None | None |
| MDA-ID-99334 | OTHER | None | None |
| NCI-610 | None | None | None |
| CDR0000068294 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |