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

Status
Active
Cancer Type
Neuroblastoma
Trial Phase
Phase I
Eligibility
30 and under, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT00646230
Protocol IDs
CDR0000584267 (primary)
NANT-2004-03
Study Sponsor
New Approaches to Neuroblastoma Therapy Consortium

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.

Objectives

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.

Treatment Sites in Georgia


Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

Study Coordinator:
Sindy Midoro

Doctors:

Dolly Aguilera MD
Tobey J. MacDonald MD
Muna Qayed MD

Aflac Cancer and Blood Disorders Center of Children’s at Scottish Rite
5455 Meridian Mark Road
Suite 400
Atlanta, GA 30342
404-785-2215
www.choa.org

Study Coordinator:
Sindy Midoro

Doctors:

Dolly Aguilera MD
Tobey J. MacDonald MD