Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Malignant Solid Tumors
- 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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of fenretinide
at end of study
Jacek Pinski, MD
USC/Norris Comprehensive Cancer Center
United States: Food and Drug Administration
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|University of California Davis Cancer Center||Sacramento, California 95817|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|Childrens Hospital Los Angeles||Los Angeles, California 90027|
|City of Hope Medical Group||Pasadena, California 91105|
|Contra Costa Regional Medical Center||Martinez, California 94553-3156|
|Texas Tech University Health Sciences Center||Lubbock, Texas 79430|