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A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation therapy after surgery followed by chemotherapy alone works in children with newly diagnosed astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.
OBJECTIVES: * Compare the event-free survival of patients with newly diagnosed anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma (DIPG) treated with adjuvant temozolomide administered concurrently with postoperative radiotherapy and then alone as maintenance therapy vs historical control cohorts treated in prior Pediatric Oncology Group and Children's Cancer Group studies. * Determine the toxicity of this regimen in these patients. * Determine the efficacy of this regimen in patients with DIPG. * Determine the toxicity of this regimen in patients with DIPG. OUTLINE: This is a multicenter study. * Adjuvant chemoradiotherapy: Beginning within 6 weeks after surgical resection or diagnosis\*, patients without gross residual disease undergo cranial irradiation 5 days a week for 6 weeks. Beginning within 6 weeks after surgical resection, patients with gross residual disease undergo radiotherapy as above followed by boost radiotherapy for 1 week. All patients receive oral temozolomide once daily beginning within 5 days after initiation of radiotherapy and continuing for a total of 6 weeks in the absence of disease progression or unacceptable toxicity. * Adjuvant maintenance therapy: Beginning 4 weeks after completion of adjuvant chemoradiotherapy, patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. NOTE: \*For patients with diffuse intrinsic pontine glioma only Patients are followed every 3-6 months for 4 years and then annually thereafter. PROJECTED ACCRUAL: A total of 50-60 patients will be accrued for this study within 12-14 months.
Age
3 - 21 years
Sex
ALL
Healthy Volunteers
No
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
University of South Alabama Cancer Research Institute
Mobile, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States
Start Date
December 1, 2002
Primary Completion Date
September 1, 2007
Completion Date
March 1, 2012
Last Updated
February 21, 2014
170
ACTUAL participants
temozolomide
DRUG
adjuvant therapy
PROCEDURE
radiation therapy
RADIATION
Lead Sponsor
Children's Oncology Group
Collaborators
NCT00602667
NCT00683319
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07416188