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

July 5, 2000
January 27, 2003
June 20, 2013
August 2000
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Complete list of historical versions of study NCT00005955 on Archive Site
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Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors
Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Neuroblastoma
Drug: temozolomide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2002
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  • 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
Sexes Eligible for Study: All
4 Years to 21 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000067936 ( Other Identifier: NCI )
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Henry Friedman, MD, Duke UMC
Duke University
National Cancer Institute (NCI)
Study Chair: Henry S. Friedman, MD Duke University
Duke University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP