Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Hematologic Malignancies
- Determine the maximum tolerated dose of intravenous emulsified fenretinide in patients
with refractory or relapsed hematologic malignancies.
- 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 pilot, dose-escalation, multicenter study.
Patients receive emulsified fenretinide IV continuously over 5 days. Treatment repeats every
21 days 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 1 patient receive accelerated escalating doses of fenretinide until 2 patients
experience moderate toxicity (cumulative across all dose levels) OR 1 patient experiences
dose-limiting toxicity (DLT). After completion of the accelerated dose-escalation portion,
the standard dose-escalation portion begins. 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 DLT. At least 6
patients are treated at the MTD. An additional 12 patients are treated at the MTD.
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: Approximately 40 patients will be accrued for this study.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete and partial response at 2 months following study completion
Ann Mohrbacher, MD
USC/Norris Comprehensive Cancer Center
United States: Food and Drug Administration
|Joe Arrington Cancer Research and Treatment Center||Lubbock, Texas 79410-1894|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|