Finding studies
Finding studies
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Lead
California Cancer Consortium
With
OBJECTIVES: * 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.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted