Temozolomide in Treating Patients With Low-Grade Glioma

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.

Detailed Description
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OBJECTIVES: Primary Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma. Secondary Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma. Assess the time to tumor progression in patients treated with temozolomide. OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Official Title
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A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma

Conditions
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CNS Tumor, Adult

Intervention / Treatment
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* Drug: temozolomide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes: Oligodendroglioma Astrocytoma Oligoastrocytoma Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma Study treatment must begin between 14 days and 4 months after surgical resection or biopsy Evaluable disease by gadolinium-MRI PATIENT CHARACTERISTICS: Karnofsky performance status 60-100% Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL Creatinine < 1.5 times upper limit of normal (ULN) BUN < 1.5 times ULN Bilirubin < 1.5 times ULN SGOT < 2.5 times ULN Alkaline phosphatase < 2 times ULN Life expectancy > 12 weeks No nonmalignant systemic disease resulting in the patient being a poor medical risk No acute infection requiring intravenous antibiotics No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin Prior malignancies must be in remission for ≥ 5 years No known HIV positivity No AIDS-related illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma No prior biological therapy or chemotherapy for low-grade glioma No other concurrent chemotherapy No concurrent radiotherapy or biological therapy No concurrent prophylactic growth factors No concurrent epoetin alfa No other concurrent investigational drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temozolomide<br>Temozolomide | Drug: temozolomide<br>* Chemotherapy<br>* Other names: Temodar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate (Complete and Partial Response) | Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was definitely better than prior scan with stable or improved neuro exam and steroids. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Tumor Progression | Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria. | time from registration until date of the first documented progression, an average of 1 year | 
| Safety Profile | Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0 | Time from registration up to 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult oligodendroglioma, adult mixed glioma, adult diffuse astrocytoma, adult pilocytic astrocytoma, adult pineal gland astrocytoma