Temozolomide in Treating Patients With Progressive Low-Grade Glioma

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: NCT00003466
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 9, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

November 1, 1999
January 27, 2003
July 9, 2014
March 1998
July 2005   (Final data collection date for primary outcome measure)
  • Response rate
  • Activity of temozolomide
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Complete list of historical versions of study NCT00003466 on Archive Site
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Temozolomide in Treating Patients With Progressive Low-Grade Glioma
Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.


  • Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide.
  • Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients.

OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma).

Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses.

Patients are followed every 8-12 weeks for 2 years.

PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years.

Phase 2
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
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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July 2005
July 2005   (Final data collection date for primary outcome measure)


  • Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including:

    • Astrocytoma
    • Oligodendroglioma
    • Mixed glioma
    • Optic pathway glioma*
    • Pontine glioma* NOTE: *Biopsy not required
  • Patients with optic pathway glioma must also meet the following criteria:

    • Progressive loss of vision as defined by doubling of octaves
    • Visual acuity loss not explained by other causes
    • Increase in proptosis of greater than 3 mm
    • Increase in diameter of optic nerve of at least 2 mm on neuroimaging
    • Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI



  • 4 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More 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)
  • SGOT and SGPT less than 2.5 times ULN
  • Alkaline phosphatase less than 2 times ULN


  • Creatinine less than 1.5 times ULN
  • BUN less than 1.5 times ULN


  • Must be neurologically stable
  • No systemic disease
  • No acute infection requiring IV antibiotics
  • No frequent vomiting
  • No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction)
  • No other prior or concurrent malignancies except:

    • Surgically cured carcinoma in situ of the cervix
    • Basal or squamous cell skin cancer
  • HIV negative
  • No AIDS-related illness
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • No concurrent biologic therapy (growth factors or epoetin alfa)


  • At least 6 weeks since prior chemotherapy unless evidence of disease progression
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • At least 6 weeks since prior radiotherapy unless evidence of disease progression
  • No concurrent radiotherapy


  • At least 3 weeks since prior surgery unless evidence of disease progression
  • Recovered from all prior surgery


  • No other concurrent investigational drugs
Sexes Eligible for Study: All
4 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
1703 (CDR0000066502)
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Duke University
Duke University
National Cancer Institute (NCI)
Study Chair: Henry S. Friedman, MD Duke Cancer Institute
Duke University
February 2013

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