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Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
This study is ongoing, but not recruiting participants.
First Received: January 21, 2000   Last Updated: July 23, 2008   History of Changes
Sponsored by: Herbert Irving Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004204
  Purpose

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 II

MedlinePlus related topics: Cancer
Drug Information available for: Temozolomide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas

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

Study Start Date: February 2000
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004204

Locations
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
Investigators
Study Chair: Casilda Balmaceda, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067449, CPMC-IRB-8622, SPRI-CPMC-IRB-8622
Study First Received: January 21, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004204     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Astrocytoma
Central Nervous System Neoplasms
Temozolomide
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioma
Antineoplastic Agents, Alkylating
Alkylating Agents
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Temozolomide
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Antineoplastic Agents, Alkylating
Glioma
Neoplasms, Neuroepithelial
Alkylating Agents
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009