Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: January 21, 2000
Last updated: January 3, 2014
Last verified: April 2006

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 Intervention Phase
Brain and Central Nervous System Tumors
Drug: temozolomide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2000
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004204     History of Changes
Other Study ID Numbers: CDR0000067449, CPMC-IRB-8622, SPRI-CPMC-IRB-8622
Study First Received: January 21, 2000
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014