NCT00646230

N2004-03: Intravenous Fenretinide in Treating Young Patients With Recurrent or Resistant Neuroblastoma

A Phase I Study of Intravenous (Emulsion) Fenretinide in Children With Recurrent or Resistant Neuroblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: New Approaches to Neuroblastoma Therapy Consortium · Academic / Other
• Sex: All
• Age: 0 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
DRUG	fenretinide
OTHER	high performance liquid chromatography
OTHER	pharmacological study

Timeline

• Start date: 2006-12-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2008-03-28
• Last updated: 2026-04-14

Locations

13 sites across 2 countries: United States, Canada