NCT00387504

Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors

Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Malignant Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: California Cancer Consortium · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	fenretinide	4-HPR (Fenretinide) is given as a continuous intravenous infusion (CIV) for five consecutive days. Cycle is repeated every 3 weeks, if PR, CR or stable disease for 6 cycles.
OTHER	pharmacological study	samples drawn per protocol

Timeline

• Start date: 2006-11-01
• Primary completion: 2013-07-01
• First posted: 2006-10-13
• Last updated: 2013-09-12

Locations

7 sites across 1 country: United States