Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00387504|
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : September 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: fenretinide Other: pharmacological study||Phase 1|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Malignant Solid Tumors|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||July 2013|
- Maximum tolerated dose (MTD) of fenretinide [ Time Frame: at end of study ]
- 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 ]
- Survival and time to failure as measured by Kaplan-Meier [ Time Frame: at end of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|