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Therapy for Children With Neuroblastoma

NCT00135135 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2008-06-03

No results posted yet for this study

Summary

This is a phase II window study of the combination of ZD1839 (gefitinib) and irinotecan in children with high-risk neuroblastoma followed by standard induction chemotherapy, intensification with autologous stem cell transplantation, and an oral maintenance phase with 13-cis-retinoic acid and topotecan. We hypothesize that the ZD1839 (gefitinib) and irinotecan window will be efficacious.

Conditions

Interventions

DRUG

Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid

See Detailed Description.

PROCEDURE

Radiation therapy, Surgery, Peripheral Stem cell transplant

See Detailed Description.

Sponsors & Collaborators

Principal Investigators

  • Wayne L Furman, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00135135 on ClinicalTrials.gov