Fenretinide Lym-X-Sorb™ in Treating Patients With Recurrent or Resistant Solid Tumors or Lymphoma
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.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: fenretinide lipid matrix
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Maximum tolerated dose of 4-HPR/LXS oral powder [ Designated as safety issue: Yes ]
- Safety [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Level of fenretinide in normal peripheral blood mononuclear cells [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||March 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589381
|United States, California|
|Childrens Hospital Los Angeles|
|Los Angeles, California, United States, 90027-0700|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90089|
|United States, Florida|
|Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital|
|Fort Lauderdale, Florida, United States, 33308|
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Shivaani Kummar, MD||NCI - Medical Oncology Branch|