Fenretinide in Treating Patients With Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00003250
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of fenretinide in treating patients who have solid tumors.

Detailed Description

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 months.

Study Timeline

• Study Start: 1998-05
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-05-20
• Study First Posted: 2004-05-21
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-09
• Last Update Posted: 2014-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determine the maximum tolerated dose (MTD) and toxicities of 4-HPR	per cycle	When drug is administered orally three times daily for 21 doses, repeated every 21 days.

Secondary Outcome Measures

Name	Time	Method
Characterize the pharmacokinetics of 4-HPR and its metabolite(s)	Pre-treatment; Cycle 1 Days 1 & 8: 1, 2, 4, 6, 8, 12, 24 hrs & day

Trial Locations

Locations (1)

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States