N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma

Completed · Phase 1

Conditions studied: Diarrhea, Drug/Agent Toxicity by Tissue/Organ, Neuroblastoma

In brief

RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Temozolomide may help irinotecan kill more tumor cells by making them more sensitive to the drug. Cefixime may be effective in preventing diarrhea that is caused by treatment with irinotecan. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and cefixime in treating young patients with recurrent or resistant neuroblastoma.

Key facts

Study ID

NCT00093353

Run by

New Approaches to Neuroblastoma Therapy Consortium

People needed

30

Starts

2004-05-01

Last updated by the study team

2026-04-14

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Lucile Packard Children's Hospital at Stanford University Medical Center — Palo Alto, California, United States
• UCSF 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
• Children's Memorial Hospital - Chicago — Chicago, Illinois, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, 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

Full record on ClinicalTrials.gov

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