Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma

Last updated: January 3, 2014
Sponsor: Herbert Irving Comprehensive Cancer Center
Overall Status: Trial Status Unknown

Phase

2

Condition

Neurofibromatosis

Brain Cancer

Brain Tumor

Treatment

N/A

Clinical Study ID

NCT00004204
CDR0000067449
CPMC-IRB-8622
SPRI-CPMC-IRB-8622
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3

  • Platelet count greater than 100,000/mm^3

  • Hemoglobin greater than 10 g/dL

Hepatic:

  • 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)

Renal:

  • BUN less than 1.5 times ULN

  • Creatinine less than 1.5 times ULN

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent epoetin alfa

Chemotherapy:

  • At least 6 weeks since other prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

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

Surgery:

  • Recovered from prior surgery

Other:

  • No other concurrent investigational agents

  • Concurrent anticonvulsant therapy allowed

Study Design

Study Start date:
February 01, 2000
Estimated Completion Date:

Study Description

OBJECTIVES:

  • 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.

Connect with a study center

  • Stanford University Medical Center

    Stanford, California 94305-5408
    United States

    Site Not Available

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois 60611-3013
    United States

    Site Not Available

  • Cancer Center of Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • Herbert Irving Comprehensive Cancer Center

    New York, New York 10032
    United States

    Site Not Available

  • Nalitt Institute for Cancer And Blood Related Diseases

    Staten Island, New York 10305
    United States

    Site Not Available

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Neurological Clinic

    Portland, Oregon 97210
    United States

    Site Not Available

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania 19104-4283
    United States

    Site Not Available

  • Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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