Protocol Number: 08-C-0030
-An experimental drug known as fenretinide has been shown in the laboratory to have activity against tumors. It has been given by mouth in capsule form to adult and child cancer patients, but because the drug is not easily absorbed in capsule form, patients must take many fenretinide capsules daily to see any effect. -A new oral preparation of fenretinide in powder form (fenretinide/LXS oral powder) may be more easily absorbed by the body, but further tests are needed to determine the safety and effectiveness of this new form. Objectives: -To test the safety of fenretinide/LXS oral powder in adults. -To determine the maximum tolerated dose of fenretinide/LXS oral powder (the highest dose that does not cause unacceptable side effects). -To see if fenretinide/LXS oral powder has any effect on patients' tumors. -To learn how the body handles and processes fenretinide/LXS oral powder. Eligibility: -Individuals 18 years of age or older who have a solid malignant tumor that has not responded to standard treatments. -Individuals who have brain tumors or other clinically significant illnesses, or who are allergic to wheat gluten, are not eligible for the study. Design: -Treatment with fenretinide/LXS oral powder for a maximum of six 21-day cycles as follows: ---Week 1 - Fenretinide/LXS oral powder mixed in a liquid nutrition supplement, applesauce, or apple juice (approximately ? to 1? cups per dose), taken twice a day. ---Weeks 2 and 3 - No fenretinide/LXS oral powder. -NOTE: Because retinoid drugs like fenretinide are known to cause birth defects, the Clinical Center will provide special gloves, masks, and mixing cups to ensure that others are not exposed to the study drug by accident. -Evaluations during the treatment period: ---Physical examinations, including vital signs and body weight checks, and pregnancy test for women who can become pregnant. ---Questions about side effects. ---Blood and urine tests. ---Inpatient visits during the first and second cycle, and clinic visits at the beginning of every cycles . Lab test required weekly, can be done by local physician ---Other special tests: ---Blood samples for pharmacokinetic studies (to measure the amount of fenretinide in the blood). ---Blood samples for pharmacodynamic studies (to measure the amount of fenretinide in white blood cells). -Post-treatment evaluations: ---End-of-study visit for blood tests, vital signs and weight measurements, disease assessment, echocardiogram, electrocardiogram, and pregnancy test for women who can become pregnant.
Search The Studies | Help | Questions |
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/17/2009
|
||