Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Malignant Solid Tumors
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.
OBJECTIVES:
- 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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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