Fenretinide Lym-X-Sorb™ in Treating Patients With Recurrent or Resistant Solid Tumors or Lymphoma

Phase 1

Completed

• Conditions: Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00589381
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fenretinide Lym-X-Sorb™ , work in different ways to stop the growth of cancer 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 Lym-X-Sorb™ in treating patients with recurrent or resistant solid tumors or lymphoma.

Detailed Description

OBJECTIVES:

Primary

* To determine the maximum tolerated dose of fenretinide Lym-X-Sorb™ oral powder (4-HPR/LXS oral powder) in patients with recurrent and/or resistant solid tumors or lymphomas.

* To define the toxicities of 4-HPR/LXS oral powder in these patients.

* To determine the plasma pharmacokinetics of 4-HPR/LXS oral powder in these patients.

Secondary

* To determine the level of fenretinide delivered as 4-HPR/LXS oral powder in normal peripheral blood mononuclear cells.

OUTLINE: This is a multicenter study.

Patients receive oral fenretinide Lym-X-Sorb™ oral powder (4-HPR/LXS oral powder) (mixed in food carriers) three times daily on days 1-7. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease response or better may receive additional courses of treatment at the discretion of the treating physician and principal investigator.

Blood samples are collected periodically for pharmacokinetic and pharmacodynamic studies.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-25
• Study First Posted: 2008-01-09
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of 4-HPR/LXS oral powder
Safety
Toxicity

Secondary Outcome Measures

Name	Time	Method
Level of fenretinide in normal peripheral blood mononuclear cells

Trial Locations

Locations (4)

Childrens Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center and Hospital; 🇺🇸 Los Angeles, California, United States

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital; 🇺🇸 Fort Lauderdale, Florida, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States