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
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.
Interventional
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of 4-HPR/LXS oral powder
Yes
Shivaani Kummar, MD
Study Chair
NCI - Medical Oncology Branch
United States: Food and Drug Administration
080030
NCT00589381
August 2007
March 2011
Name | Location |
---|---|
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Childrens Hospital Los Angeles | Los Angeles, California 90027 |
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda, Maryland 20892-1182 |