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Trial record 12 of 29 for:    "Teratoma" | "Antineoplastic Agents, Alkylating"

Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005955
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
National Cancer Institute (NCI)
Information provided by:
Duke University

Brief Summary:

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. Chemotherapy combined with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by radiation therapy in treating children who have newly diagnosed malignant central nervous system tumors.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Neuroblastoma Drug: temozolomide Phase 2

Detailed Description:


  • Determine the response rate to treatment with temozolomide in children with newly diagnosed malignant central nervous system tumors.
  • Determine the toxicity of this treatment in these patients.
  • Determine the overall survival in these patients for 18 months following the study after receiving this treatment.

OUTLINE: Patients are stratified according to type of disease (ependymoma vs brain stem glioma vs malignant glioma vs other).

Patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial or complete response may receive an additional 8 courses of temozolomide following radiotherapy.

PROJECTED ACCRUAL: A maximum of 100 patients (25 per stratum) will be accrued for this study over 24-36 months.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy
Study Start Date : August 2000
Actual Study Completion Date : September 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed newly diagnosed malignant central nervous system tumor not requiring immediate radiotherapy
  • Patients with diffuse pontine tumors do not require histological confirmation
  • Eligible types include the following:

    • Ependymoma
    • Malignant glioma

      • Anaplastic astrocytoma
      • Glioblastoma multiforme
      • Anaplastic oligodendroglioma
      • Gliosarcoma
      • Anaplastic mixed oligoastrocytoma
    • Brainstem glioma
    • Primitive neuroectodermal tumor
    • Nongerminoma germ cell tumor
  • At least one bidimensionally measurable lesion

    • At least 1.5 cm2 within 72 hours of surgical resection or greater than 14 days after surgery
    • Diffuse pontine tumors are not required to be measurable
  • Neurologically stable



  • 4 to 21

Performance status:

  • Karnofsky or Lansky 70-100%

Life expectancy:

  • Greater than 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 2 times ULN
  • SGOT and SGPT less than 2.5 times ULN


  • BUN and creatinine less than 1.5 times ULN


  • Must be able to swallow capsules
  • No acute infection treated with intravenous antibiotics
  • No nonmalignant systemic disease that makes patient a poor medical risk
  • No frequent vomiting or medical condition that may interfere with oral medication intake (e.g., partial bowel obstruction)
  • No other prior or concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • No more than one prior biologic therapy regimen
  • No concurrent biologic therapy
  • No concurrent growth factors or epoetin alfa


  • No more than one prior chemotherapy regimen
  • No other concurrent chemotherapy

Endocrine therapy:

  • No increasing doses of steroids within one week of study


  • See Disease Characteristics
  • No concurrent radiotherapy


  • At least 2 weeks, but no greater than 4 weeks, since prior surgical resection and recovered


  • No other concurrent investigational drugs

Information from the National Library of Medicine

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 identifier (NCT number): NCT00005955

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United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
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Study Chair: Henry S. Friedman, MD Duke University

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Responsible Party: Henry Friedman, MD, Duke UMC Identifier: NCT00005955     History of Changes
Other Study ID Numbers: 0931
CDR0000067936 ( Other Identifier: NCI )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: October 2009
Keywords provided by Duke University:
childhood central nervous system teratoma
childhood infratentorial ependymoma
childhood low-grade cerebral astrocytoma
childhood supratentorial ependymoma
childhood craniopharyngioma
localized resectable neuroblastoma
regional neuroblastoma
disseminated neuroblastoma
stage 4S neuroblastoma
childhood high-grade cerebral astrocytoma
childhood oligodendroglioma
childhood choroid plexus tumor
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
untreated childhood supratentorial primitive neuroectodermal tumor
untreated childhood cerebellar astrocytoma
untreated childhood medulloblastoma
untreated childhood visual pathway and hypothalamic glioma
newly diagnosed childhood ependymoma
childhood central nervous system choriocarcinoma
childhood central nervous system embryonal tumor
childhood central nervous system mixed germ cell tumor
childhood central nervous system yolk sac tumor
Additional relevant MeSH terms:
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Antineoplastic Agents, Alkylating
Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
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
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents