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Temozolomide in Treating Patients With Recurrent Malignant Glioma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004113
  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 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 (SCH 52365, Temodal(R)) for the Treatment of Recurrent Malignant Glioma

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

Study Start Date:   June 1999

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.

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

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004113

Locations
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)

Investigators
Study Chair:     Lauren E. Abrey, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000067337, MSKCC-IRB-99019, NCI-G99-1602
First Received:   December 10, 1999
Last Updated:   November 22, 2008
ClinicalTrials.gov Identifier:   NCT00004113
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor  
adult glioblastoma  
adult anaplastic astrocytoma  
adult anaplastic oligodendroglioma  
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma

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

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

ClinicalTrials.gov processed this record on November 30, 2008




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