Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387504
Status:
COMPLETED
Last Update Posted:
2013-09-12
First Post:
2006-10-12
Brief Title:
Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors
Sponsor:
California Cancer Consortium
Organization:
California Cancer Consortium
Study Overview
Official Title:
Phase I Trial of Intravenous Fenretinide 4-HPR for Patients With Malignant Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-09
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 such as fenretinide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase I trial is studying the side effects and best dose of fenretinide in treating patients with metastatic or unresectable malignant solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of fenretinide in treating patients with metastatic or unresectable malignant solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of fenretinide in patients with metastatic or unresectable malignant solid tumors
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics and in vivo activity of this drug in these patients
Determine preliminarily disease or tumor response in patients treated with this drug
OUTLINE This is a dose-escalation multicenter study
Patients receive fenretinide IV continuously on days 1-5 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete or partial response may continue to receive fenretinide at the discretion of the study chair
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 At least 6 patients are treated at the MTD
Patients undergo blood sample collection to determine plasma concentrations pharmacokinetics of fenretinide periodically during course 1 and at the end of courses 2-6
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 21 patients will be accrued for this study
Determine the maximum tolerated dose of fenretinide in patients with metastatic or unresectable malignant solid tumors
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics and in vivo activity of this drug in these patients
Determine preliminarily disease or tumor response in patients treated with this drug
OUTLINE This is a dose-escalation multicenter study
Patients receive fenretinide IV continuously on days 1-5 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete or partial response may continue to receive fenretinide at the discretion of the study chair
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 At least 6 patients are treated at the MTD
Patients undergo blood sample collection to determine plasma concentrations pharmacokinetics of fenretinide periodically during course 1 and at the end of courses 2-6
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 21 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 |
|---|---|---|---|
| NCI-7540 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01CA062505 |
| U01CA062505 | NIH | None | None |
| CCC-PHI-54 | None | None | None |