Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-26 @ 6:11 AM
Study NCT ID:
NCT00387504
Status:
COMPLETED
Last Update Posted:
2013-09-12
First Post:
2006-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors
Sponsor:
California Cancer Consortium
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01CA062505 | NIH | None | https://reporter.nih.gov/quic… | View |
| CCC-PHI-54 | None | None | View | |
| NCI-7540 | None | None | View |