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Temozolomide in Treating Patients With Recurrent 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: NCT00004113
Recruitment Status : Completed
First Posted : May 21, 2004
Last Update Posted : June 19, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

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 malignant glioma.

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

Detailed Description:

OBJECTIVES: I. Determine the safety and efficacy of temozolomide in patients with recurrent malignant glioma. II. Determine the radiographic response to this regimen in these patients. III. Determine the time to tumor progression of these patients on this regimen. IV. Determine the quality of life of these patients.

OUTLINE: Patients receive oral temozolomide once daily for 42 days. Courses repeat every 70 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed every 1-2 months. Patients are followed every 3-4 months.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 2 years.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of Temozolomide (SCH 52365, Temodal(R)) for the Treatment of Recurrent Malignant Glioma
Study Start Date : June 1999
Actual Primary Completion Date : October 2001
Actual Study Completion Date : October 2001

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

DISEASE CHARACTERISTICS: Histologically confirmed recurrent malignant glioma, including: Glioblastoma Gliosarcoma High grade glioma Anaplastic astrocytoma Anaplastic mixed oligoastrocytoma Anaplastic oligodendroglioma Must have evidence of tumor recurrence or progression on gadolinium enhanced MRI or CT scan following radiotherapy with or without chemotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and SGPT less than 3 times ULN Alkaline phosphatase less than 2 times ULN Renal: Creatinine less than 1.5 times ULN BUN less than 1.5 times ULN Other: No nonmalignant systemic disease that would cause patient to be a poor medical risk No acute infection requiring intravenous antibiotics No psychological disorder that would interfere with study compliance HIV negative No AIDS-related illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) No prior or concurrent malignancy, except: Surgically cured carcinoma in situ of the cervix Basal or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy At least 4 weeks since prior biologic therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No prior temozolomide or dacarbazine Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior external beam radiotherapy At least 8 weeks since prior stereotactic radiosurgery Surgery: At least 2 weeks since prior brain biopsy, craniotomy, or other surgery

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): NCT00004113

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Lauren E. Abrey, MD Memorial Sloan Kettering Cancer Center
Publications of Results:
Layout table for additonal information Identifier: NCT00004113    
Other Study ID Numbers: 99-019
CDR0000067337 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 21, 2004    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult mixed glioma
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