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Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

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: NCT00003464
Recruitment Status : Completed
First Posted : August 20, 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.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating adults with newly diagnosed primary malignant glioblastoma multiforme.

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

Detailed Description:


  • Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme.
  • Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients.
  • Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide.

OUTLINE: Patients receive temozolomide orally once daily on days 1-5. Treatment courses are repeated every 28 days. In the absence of disease progression and toxicity, patients receive up to 4 courses of treatment prior to radiation therapy. After radiation therapy, patients demonstrating partial or complete response may receive an additional 12 courses of treatment.

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

PROJECTED ACCRUAL: This study will accrue 50 patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Primary Purpose: Treatment
Official Title: Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal
Study Start Date : September 1997
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven, newly diagnosed, supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy
  • At least 1 bidimensionally measurable lesion



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Greater than 12 weeks


  • Absolute neutrophil count at least 1500/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


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


  • Must be neurologically stable
  • No systemic disease
  • No acute infection requiring intravenous antibiotics
  • No frequent vomiting
  • No other medical condition that would interfere with oral medication intake such as partial bowel obstruction
  • No prior or concurrent malignancies except:

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


Biologic therapy:

  • No prior biologic therapy
  • No concurrent biologic therapy (growth factors or erythropoietin)


  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent steroid allowed (must be on stable dose for at least 1 week prior to study)


  • No prior radiation therapy
  • No prior interstitial brachytherapy
  • No prior radiosurgery to the brain
  • Not requiring immediate radiation therapy
  • No concurrent radiotherapy


  • Recovered from any effects of prior surgery
  • At least 2 weeks since prior surgical resection


  • 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): NCT00003464

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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: NCT00003464    
Other Study ID Numbers: 1171
CDR0000066498 ( Other Identifier: NCI )
First Posted: August 20, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: October 2009
Keywords provided by Duke University:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
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