Temozolomide in Treating Patients With Recurrent or Progressive Malignant 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: NCT00004204
Recruitment Status : Unknown
Verified April 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : July 18, 2003
Last Update Posted : January 6, 2014
Information provided by:
National Cancer Institute (NCI)

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 patients who have recurrent or progressive malignant glioma.

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

Detailed Description:


  • Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide.
  • Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma).

Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas
Study Start Date : February 2000

Information from the National Library of Medicine

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


  • Histologically proven recurrent or progressive malignant glioma of one of the following types:

    • Anaplastic oligodendroglioma or oligoastrocytoma
    • Anaplastic astrocytoma
    • Glioblastoma multiforme (stratum closed to accrual 11/30/01)
  • Patients who have failed radiotherapy are eligible
  • Measurable disease by CT scan or MRI



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 12 weeks


  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 10 g/dL


  • SGOT or SGPT less than 3 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed)


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


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No other serious concurrent infection or other medical illness that would preclude study entry
  • No frequent vomiting or partial bowel obstruction
  • HIV negative
  • No AIDS-related illness
  • No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer


Biologic therapy:

  • No concurrent epoetin alfa


  • At least 6 weeks since other prior chemotherapy

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator)


  • Recovered from prior surgery


  • No other concurrent investigational agents
  • Concurrent anticonvulsant therapy allowed

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): NCT00004204

United States, California
Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, Florida
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Nalitt Institute for Cancer And Blood Related Diseases
Staten Island, New York, United States, 10305
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Oregon
Neurological Clinic
Portland, Oregon, United States, 97210
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Wisconsin
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
Study Chair: Casilda Balmaceda, MD Herbert Irving Comprehensive Cancer Center Identifier: NCT00004204     History of Changes
Other Study ID Numbers: CDR0000067449
First Posted: July 18, 2003    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: April 2006

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma

Additional relevant MeSH terms:
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