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Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: January 4, 2002
Last updated: February 19, 2014
Last verified: February 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 Intervention Phase
Brain and Central Nervous System Tumors
Drug: temozolomide
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma

Resource links provided by NLM:

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Improved outcome
  • Toxicity as assessed by NCI CTCAE v. 2.0

Enrollment: 170
Study Start Date: December 2002
Study Completion Date: March 2012
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemoradiotherapy Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy

Detailed Description:


  • 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.


Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed newly diagnosed CNS tumor of the following types:

    • High grade glioma (HGG) of one of the following histologies:

      • Anaplastic astrocytoma (grade III)
      • Glioblastoma multiforme (grade IV)
      • Gliosarcoma
      • Primary spinal cord malignant glioma
    • Diffuse intrinsic pontine glioma (DIPG)

      • Diagnosed by gadolinium-enhanced MRI
      • At least 2/3 of tumor situated in the pons AND tumor clearly originated in the pons
      • No diffuse leptomeningeal disease
      • No tumors with features not typical of diffuse intrinsic brainstem glioma, including any of the following:

        • Dorsally exophytic brainstem glioma
        • Cervico-medullary junction tumor
        • Focal low-grade glioma of the midbrain or brainstem
      • No diffuse brainstem enlargement due to neurofibromatosis
  • No primary brain stem malignant glioma
  • No M+ disease (CSF positive for tumor or metastatic disease)
  • Must begin study radiotherapy within 6 weeks after surgical resection (for HGG patients) or diagnosis (for DIPG patients)



  • 3 to 21

Performance status:

  • Karnofsky 50-100% OR
  • Lansky 50-100%

Life expectancy:

  • At least 2 months


  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3*
  • Hemoglobin at least 10.0 g/dL* NOTE: *Transfusion independent


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT less than 2.5 times ULN


  • Creatinine no greater than 1.5 times ULN


  • No other concurrent malignancy
  • Concurrent seizure disorder allowed if well controlled on anticonvulsants
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after completion of study treatment



  • No concurrent routine cytokine support


  • Not specified

Endocrine therapy:

  • No concurrent corticosteroids except for increased intracranial pressure in patients with CNS tumors


  • See Disease Characteristics


  • See Disease Characteristics


  • No prior therapy for HGG or DIPG
  Contacts and Locations
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Please refer to this study by its identifier: NCT00028795

  Show 230 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Kenneth J. Cohen, MD, MBA Sidney Kimmel Comprehensive Cancer Center
  More Information


Responsible Party: Children's Oncology Group Identifier: NCT00028795     History of Changes
Other Study ID Numbers: ACNS0126
COG-ACNS0126 ( Other Identifier: Children's Oncology Group )
CDR0000069135 ( Other Identifier: Clinical )
Study First Received: January 4, 2002
Last Updated: February 19, 2014

Keywords provided by Children's Oncology Group:
childhood brain stem glioma
childhood high-grade cerebral astrocytoma
childhood spinal cord neoplasm
untreated childhood brain stem glioma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on April 26, 2017