Temozolomide in Treating Patients With Progressive Low-Grade Glioma

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.

Detailed Description
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OBJECTIVES: Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide. Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients. OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma). Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses. Patients are followed every 8-12 weeks for 2 years. PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years.

Official Title
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Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: temozolomide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including: Astrocytoma Oligodendroglioma Mixed glioma Optic pathway glioma* Pontine glioma* NOTE: *Biopsy not required Patients with optic pathway glioma must also meet the following criteria: Progressive loss of vision as defined by doubling of octaves Visual acuity loss not explained by other causes Increase in proptosis of greater than 3 mm Increase in diameter of optic nerve of at least 2 mm on neuroimaging Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI PATIENT CHARACTERISTICS: Age: 4 and over Performance status: Karnofsky 70-100% Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and SGPT less than 2.5 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: Must be neurologically stable No systemic disease No acute infection requiring IV antibiotics No frequent vomiting No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction) No other prior or concurrent malignancies except: Surgically cured carcinoma in situ of the cervix Basal or squamous cell skin cancer HIV negative No AIDS-related illness Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy (growth factors or epoetin alfa) Chemotherapy: At least 6 weeks since prior chemotherapy unless evidence of disease progression No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since prior radiotherapy unless evidence of disease progression No concurrent radiotherapy Surgery: At least 3 weeks since prior surgery unless evidence of disease progression Recovered from all prior surgery Other: No other concurrent investigational drugs

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: temozolomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Activity of temozolomide |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult brain tumor, adult mixed glioma, childhood mixed glioma, adult pilocytic astrocytoma, adult subependymoma, recurrent childhood cerebral astrocytoma, adult brain stem glioma, recurrent childhood brain stem glioma, untreated childhood brain stem glioma, recurrent childhood visual pathway and hypothalamic glioma, untreated childhood visual pathway and hypothalamic glioma, adult oligodendroglioma, adult diffuse astrocytoma