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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

Brief Summary:

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.

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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Primary Purpose: Treatment
Official Title: Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal
Study Start Date : March 1998
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Primary Outcome Measures :
  1. Response rate
  2. Activity of temozolomide

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

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): NCT00003466

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United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4318
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
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Study Chair: Henry S. Friedman, MD Duke Cancer Institute

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Responsible Party: Duke University Identifier: NCT00003466     History of Changes
Other Study ID Numbers: 1703 (CDR0000066502)
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: February 2013

Keywords provided by Duke University:
recurrent adult brain tumor
adult mixed glioma
childhood mixed glioma
adult pilocytic astrocytoma
adult subependymoma
recurrent childhood cerebral astrocytoma
adult brain stem glioma
recurrent childhood brain stem glioma
untreated childhood brain stem glioma
recurrent childhood visual pathway and hypothalamic glioma
untreated childhood visual pathway and hypothalamic glioma
adult oligodendroglioma
adult diffuse astrocytoma

Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
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
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents