Prolonged Daily Temozolomide for Low-Grade Glioma

Study Overview
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Brief Summary
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The purpose of this trial is to determine the effects (good and bad) temozolomide has on patients with low-grade glioma. It will also determine whether temozolomide is effective in preventing or delaying future tumor growth.

Detailed Description
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Treatment with temozolomide is based upon an 11-week cycle (7 weeks on the drug and 4 weeks off). Patients will receive temozolomide once daily for 49 days, then have 28 days without taking temozolomide. Every two to four weeks a physical and neurological examination and blood work will be performed. A magnetic resonance imaging (MRI) scan of the patient's brain will be done approximately every three months (before each cycle of treatment). Treatment may continue for a maximum of a year and a half based on 6 eleven-week cycles. The actual duration of therapy will depend upon the response to treatment and the development of side effects or toxicity.

Official Title
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A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma

Conditions
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Glioma, Astrocytoma, Oligodendroglioma

Intervention / Treatment
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* Drug: Temozolomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological confirmation of a low-grade glioma (astrocytoma, oligodendroglioma, or mixed oligoastrocytoma) Measurable disease on MRI Patients that have undergone recent resection for newly diagnosed or recurrent or progressive tumor are eligible if they have recovered from the effects of surgery. Patients with recurrent disease my have had one prior chemotherapy regimen Older than 18 years of age. Karnofsky performance status (KPS) performance score of > 70% Adequate hematologic, renal and liver functions, Life expectancy of greater than 12 weeks. Negative pregnancy test. Exclusion Criteria: Prior treatment with temozolomide Patients who are not neurologically stable Acute infection treated with intravenous antibiotics Non-malignant systemic disease Frequent vomiting, inability to swallow or a medical condition that could interfere with oral medication. Previous or concurrent malignancies at other sites, with the exception of surgically cured carcinoma in-situ of the cervix, and basal or squamous cell carcinoma of the skin. HIV positive or AIDS-related illness Pregnant or nursing women Patients with allergy to decarbazine.

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Temozolomide|Given once daily for 49 days followed by 28 days with no drug for a maximum of a year and a half|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects temozolomide has on low-grade gliomas |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether temozolomide is effective in preventing or delaying future tumor growth |  | 3 years | 
| to determine the safety of temozolomide |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-grade glioma, astrocytoma, oligodendroglioma, oligoastrocytoma, temozolomide, mixed oligoastrocytoma