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Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas

NCT00042991 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2014-05-28

Study results available
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Summary

Biological therapies such as gefitinib may interfere with the growth of the tumor cells and may make the tumor cells more sensitive to radiation therapy. This phase I/II trial is studying how well giving gefitinib together with radiation therapy works in treating children with newly diagnosed glioma.

Conditions

  • Untreated Childhood Anaplastic Astrocytoma
  • Untreated Childhood Anaplastic Oligodendroglioma
  • Untreated Childhood Brain Stem Glioma
  • Untreated Childhood Giant Cell Glioblastoma
  • Untreated Childhood Glioblastoma
  • Untreated Childhood Gliomatosis Cerebri
  • Untreated Childhood Gliosarcoma
  • Untreated Childhood Oligodendroglioma

Interventions

DRUG

gefitinib

Given orally

RADIATION

radiation therapy

Undergo standard brain irradiation

OTHER

pharmacological study

Correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Jeffrey Geyer · Pediatric Brain Tumor Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2010-02-28
Completion
2010-03-31

Countries

  • United States

Study Locations

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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 NCT00042991 on ClinicalTrials.gov