Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma

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 newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.

Detailed Description
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OBJECTIVES: Determine progression-free survival of patients with newly diagnosed anaplastic oligodendroglioma (AO) or mixed oligoastrocytoma (MOA) treated with temozolomide. Determine the response rate in these patients. Assess the quality of life of patients with AO or MOA treated with this regimen. OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to disease type (anaplastic oligodendroglioma vs mixed oligoastrocytoma). Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before courses 1, 3, 5, and 7, every 3 months for the first year after completion of treatment, every 4 months for the second year, every 6 months for the third and fourth years, and once a year thereafter. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Official Title
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Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma

Conditions
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Central Nervous System Tumors, Brain Tumor

Intervention / Treatment
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* Drug: temozolomide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed anaplastic oligodendroglioma or mixed oligoastrocytoma meeting 1 of the following criteria: Bidimensionally measurable disease Evaluable disease Nonevaluable disease as demonstrated by gross total surgical resection No immediate need for cranial irradiation PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% Life expectancy ≥ 12 weeks Absolute granulocyte count ≥ 1,500/mm³ Hemoglobin ≥ 10.0 g/dL Platelet count ≥ 100,000/mm³ Creatinine ≤ 1.5 times upper limit of normal (ULN) Bilirubin ≤ 2.0 times ULN AST ≤ 3.0 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No infection requiring systemic antibiotics within the past 14 days No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer No unrelated medical problems that would preclude study compliance PRIOR CONCURRENT THERAPY: No prior chemotherapy for this malignancy No prior radiotherapy to the brain No surgery requiring general anesthesia > 2 hours in duration within the past 10 days No prior temozolomide Concurrent steroids allowed provided dose is stable or decreasing for at least 1 week prior to study entry

Ages Eligible for Study
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Minimum Age: 18 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, 150 mg/m2/d x days 1-7 and 15-21 | Drug: temozolomide<br>* Schedule of Temozolomide administration: Temozolomide, 150 mg/m2/d x days 1-7 and 15-21, given every 28 days [i.e., 7 days on/7 days off]<br>* Other names: Temodar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival | Time in months to patient's disease progresses | Survival of Last Patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity--Count of Related Advers Events | Count of Treatment Related Toxicities | Post-Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult anaplastic oligodendroglioma, adult mixed glioma