Phase I Evaluation of Fenretinide (NSC# 374551)
OBJECTIVES: I. Determine the maximum tolerated dose and toxicity of oral fenretinide in
patients with solid malignant tumors. II. Determine the pharmacokinetics of fenretinide and
its metabolites. III. Determine the preliminary antitumor activity of fenretinide in this
patient population. IV. Determine the recommended phase II starting dose of fenretinide. V.
Determine whether fenretinide induces apoptosis in clinical specimens.
OUTLINE: This is a dose escalation study. Patients receive oral fenretinide once daily on
days 1, 8 and 9 and three times a day on days 2-7. Courses repeat every 3 weeks in the
absence of disease progression or unacceptable toxicity. Treatment continues for up to 6
months following complete remission. Accessible tumors are biopsied on day 8. 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.
PROJECTED ACCRUAL: Approximately 21 patients will be accrued for this study within 6-9
Primary Purpose: Treatment
Patricia M. LoRusso, DO
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|