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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
Maximum tolerated dose of 4-HPR/LXS oral powder
Safety
Toxicity
Level of fenretinide in normal peripheral blood mononuclear cells
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