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

NCT00093353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

cefixime

DRUG

irinotecan hydrochloride

DRUG

temozolomide

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • New Approaches to Neuroblastoma Therapy Consortium

    lead OTHER

Principal Investigators

  • Lars M. Wagner, MD · Children's Hospital Medical Center, Cincinnati

  • Katherine K. Matthay, MD · University of California, San Francisco

Study Design

Purpose
TREATMENT

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2006-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00093353 on ClinicalTrials.gov