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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

Tracking Information
First Submitted Date  ICMJE July 5, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date June 20, 2013
Study Start Date  ICMJE August 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00005955 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors
Official Title  ICMJE Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Brain and Central Nervous System Tumors
  • Neuroblastoma
Intervention  ICMJE Drug: temozolomide
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE


  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00005955
Other Study ID Numbers  ICMJE 0931
CDR0000067936 ( Other Identifier: NCI )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Henry Friedman, MD, Duke UMC
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Henry S. Friedman, MD Duke University
PRS Account Duke University
Verification Date October 2009

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