Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma
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|ClinicalTrials.gov Identifier: NCT00028795|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 21, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||March 2012|
Procedure: adjuvant therapy
Radiation: radiation therapy
- Improved outcome
- Toxicity as assessed by NCI CTCAE v. 2.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028795
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|Study Chair:||Kenneth J. Cohen, MD, MBA||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|