Clinical Trials Directory

Trials / Completed

CompletedNCT00589381

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

Phase I Trial of Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb™ (LXS) Oral Powder (4-HPR/LXS Oral Powder) (4-HPR) in Adults With Solid Tumors and Lymphomas

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
National Institutes of Health Clinical Center (CC) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGfenretinide lipid matrix

Timeline

Start date
2007-08-01
Primary completion
2010-12-01
Completion
2011-03-01
First posted
2008-01-09
Last updated
2012-03-08

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00589381. Inclusion in this directory is not an endorsement.