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A Phase II Study of Temozolomide (SCH 52365, Temodal(R)) for the Treatment of Recurrent Malignant Glioma

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Phase II Study of Temozolomide (SCH 52365, Temodal(R)) for the Treatment of Recurrent Malignant Glioma

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.

Inclusion 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

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Lauren E. Abrey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 1999

Completion Date:

October 2001

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021