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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.

Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028795
  Purpose

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
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer   

Drug Information available for:   Temozolomide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Improved outcome [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v. 2.0 [ Designated as safety issue: Yes ]

Study Start Date:   December 2002

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

Age:

  • 3 to 21

Performance status:

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

Life expectancy:

  • At least 2 months

Hematopoietic:

  • 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

Hepatic:

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

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic:

  • No concurrent routine cytokine support

Chemotherapy:

  • Not specified

Endocrine therapy:

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

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics

Other:

  • No prior therapy for HGG or DIPG
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028795

Show 230 study locations  Show 230 Study Locations

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Kenneth J. Cohen, MD     Sidney Kimmel Comprehensive Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000069135, COG-ACNS0126
First Received:   January 4, 2002
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00028795
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood brain stem glioma  
childhood high-grade cerebral astrocytoma  
childhood spinal cord neoplasm  
untreated childhood brain stem glioma  

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Spinal cord neoplasm
Central Nervous System Neoplasms
Temozolomide
Neuroectodermal Tumors
Glioblastoma multiforme
Neoplasms, Germ Cell and Embryonal
Spinal Cord Neoplasms
Neuroepithelioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Nervous System Diseases
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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