Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors
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.
Unspecified Adult Solid Tumor, Protocol Specific
Other: pharmacological study
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Malignant Solid Tumors|
- Maximum tolerated dose (MTD) of fenretinide [ Time Frame: at end of study ] [ Designated as safety issue: Yes ]
- Toxicity as measured by type (organ affected or laboratory determination such as absolute neutrophil count), severity (NCI CTCAE v3.0), time of onset (course number), duration, and reversibility or outcome [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
- Survival and time to failure as measured by Kaplan-Meier [ Time Frame: at end of study ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387504
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Childrens Hospital Los Angeles|
|Los Angeles, California, United States, 90027-0700|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90089-9181|
|Contra Costa Regional Medical Center|
|Martinez, California, United States, 94553|
|City of Hope Medical Group|
|Pasadena, California, United States, 91105|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|United States, Texas|
|Texas Tech University Health Sciences Center|
|Lubbock, Texas, United States, 79430|
|Study Chair:||Jacek Pinski, MD||University of Southern California|