N2004-03: Intravenous Fenretinide in Treating Young Patients With Recurrent or Resistant Neuroblastoma
- Conditions
- Neuroblastoma
- Interventions
- Registration Number
- NCT00646230
- Lead Sponsor
- Nant Operations Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm of CIV infusion of emulsion 4-HPR fenretinide Single arm study of continuous intravenous infusion (CIV) of emulsion 4-HPR Single arm of CIV infusion of emulsion 4-HPR high performance liquid chromatography Single arm study of continuous intravenous infusion (CIV) of emulsion 4-HPR Single arm of CIV infusion of emulsion 4-HPR pharmacological study Single arm study of continuous intravenous infusion (CIV) of emulsion 4-HPR
- Primary Outcome Measures
Name Time Method To determine the plasma pharmacokinetics of intravenous emulsion 4-HPR given on this schedule. Pharmacokinetic Profile of Fenretinide - blood levels to be measured in Cycle #1 D0 Hr0, Hrs 6, 12, 24, 36, 48, 72, 96, 120 and end of infusion, then +2 hrs, +48 hrs post infusion. Cycle #2 D1 Hr0 (pre-infusion), then +48 hrs, at the end of infusion. To define the toxicities of intravenous emulsion 4-HPR given on this schedule. Adverse events, clinically significant changes in lab results or vitals will be captured throughout the duration of the study. Adverse events, clinically significant changes in lab results or vitals will be captured throughout the duration of the study.
To determine the maximum tolerated dose of intravenous emulsion 4-HPR given as a continuous intravenous infusion (CIV) for five days (120 hours) every three weeks in children with recurrent and/or resistant neuroblastoma. Tolerability of drug will be assessed throughout the study.
- Secondary Outcome Measures
Name Time Method To determine the response rate to intravenous emulsion 4-HPR in patients with recurrent and/or resistant neuroblastoma within the confines of a Phase I study. Disease response will be assessed at baseline, End of Cycle #2, End of Cycle #6 and every 4 weeks thereafter. Response will be measured utilizing any of the following;CT scan, MRI, MIBG scan, Bone Marrow, Urine Catecholamines
To determine the bioavailability to tumor cells of 4-HPR delivered as an intravenous emulsion in normal peripheral blood mononuclear cells (PBMC) as a tumor cell surrogate tissue. Assessed Cycle #1 D0 Hr0, D2, +48hrs after start of infusion and C#2 one time for patients >20kg. To describe the results of the five gene Five-gene TaqMan® Low Density Array (TLDA) assay for neuroblastoma tumor cells in the bone marrow done at timepoints when bone marrow response is being evaluated by morphology during this therapy. Assessed at the end of Cycle #2 & Cycle #6 and then every 4 cycles therafter.
Trial Locations
- Locations (13)
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
🇺🇸Atlanta, Georgia, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
🇺🇸Houston, Texas, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
University of Chicago Comer Children's Hospital
🇺🇸Chicago, Illinois, 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
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States