Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003250
Status:
COMPLETED
Last Update Posted:
2014-04-11
First Post:
1999-11-01
Brief Title:
Fenretinide in Treating Patients With Solid Tumors
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase I Evaluation of Fenretinide NSC 374551
Status:
COMPLETED
Status Verified Date:
2014-04
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 I trial to study the effectiveness of fenretinide in treating patients who have solid tumors
PURPOSE Phase I trial to study the effectiveness of fenretinide in treating patients who have solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and toxicity of oral fenretinide in patients with solid malignant tumors II Determine the pharmacokinetics of fenretinide and its metabolites III Determine the preliminary antitumor activity of fenretinide in this patient population IV Determine the recommended phase II starting dose of fenretinide V Determine whether fenretinide induces apoptosis in clinical specimens
OUTLINE This is a dose escalation study Patients receive oral fenretinide once daily on days 1 8 and 9 and three times a day on days 2-7 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Treatment continues for up to 6 months following complete remission Accessible tumors are biopsied on day 8 Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 21 patients will be accrued for this study within 6-9 months
OUTLINE This is a dose escalation study Patients receive oral fenretinide once daily on days 1 8 and 9 and three times a day on days 2-7 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Treatment continues for up to 6 months following complete remission Accessible tumors are biopsied on day 8 Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 21 patients will be accrued for this study within 6-9 months
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 |
|---|---|---|---|
| NCI-T97-0098 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| U01CA062487 | NIH | None | None |
| P30CA022453 | NIH | None | None |
| WSU-C-1605 | None | None | None |