Spots Global Cancer Trial Database for N2004-03: Intravenous Fenretinide in Treating Young Patients With Recurrent or Resistant Neuroblastoma
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Trial Identification
Brief Title: N2004-03: Intravenous Fenretinide in Treating Young Patients With Recurrent or Resistant Neuroblastoma
Official Title: A Phase I Study of Intravenous (Emulsion) Fenretinide in Children With Recurrent or Resistant Neuroblastoma
Study ID: NCT00646230
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor 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 intravenous fenretinide in treating young patients with recurrent or resistant neuroblastoma.
Detailed Description: OBJECTIVES: Primary * To determine the maximum tolerated dose of fenretinide when given as a continuous intravenous infusion in young patients with recurrent and/or resistant neuroblastoma. * To define the toxicities of this drug in these patients. * To determine the plasma pharmacokinetics of this drug in these patients. Secondary * To determine the response rate in patients treated with this drug. * To determine the bioavailability of fenretinide in normal peripheral blood mononuclear cells as a surrogate marker for drug bioavailability to tumor tissue. OUTLINE: This is a multicenter study. Patients receive fenretinide IV continuously over 120 hours on days 0-4. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically for pharmacokinetic analysis by high performance liquid chromatography. After completion of study treatment, patients are followed periodically.
Keywords
Eligibility
Minimum Age: 0 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Childrens Hospital Los Angeles, Los Angeles, California, United States
Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, United States
University of Chicago Comer Children's Hospital, Chicago, Illinois, United States
Children's Hospital Boston, Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan, United States
Morgan Stanley Children's Hospital of New York-Presbyterian, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital, Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Hospital for Sick Children, Toronto, Ontario, Canada
Contact Details
Name: Barry J. Maurer, MD, PhD
Affiliation: Texas Tech University Health Sciences Center
Role: STUDY_CHAIR
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