Temozolomide in Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: Single-arm, Phase II Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of temozolomide in patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma.

Detailed Description
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Patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma will be enrolled. Enrolled patients will begin on temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle). Patients who were previously treated with any chemotherapy initially received temozolomide 150 mg/m2/d for 5 days (750 mg/m2 per cycle).Patients will be receving a total 6 cycles of chemotheray (4weeks/cycle * 6cycles = 24weeks). If the patients shows responses to Temozolomide, treatment can be continued by the investigator's discretion. During the administration of Temozolomide, vital signs, physical examination, ECOG performance status, height, weight, hematology and chemistry test, adverse events and concomitant drugs will be evaluated every four weeks. Brain MRI for tumor assessment will be performed once every 12 weeks.

Official Title
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The Efficacy and Safety of Temozolomide in Patients With Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: a Multicenter, Single-arm, Phase II Trial

Conditions
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Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma

Intervention / Treatment
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* Drug: Temozolomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven anaplastic oligodendroglioma or oligoastrocytoma Progressed or relapsed after surgery or radiation therapy Female or male aged 20 years or over At least 1 measurable mass lesion ECOG performance status 0-3 Adequate organ function absolute neutrophil count > 1,500/μL platelet count > 75,000/μL hemoglobin greater than 9 g/dL or 900g/L serum creatinine less than 1.5 times the upper limit of laboratory normal total serum bilirubin less than 1.5 times the upper limit of laboratory normal AST or ALT less than three times the upper limit of laboratory normal Exclusion Criteria: Prior course of temozolomide Combined glioblastoma Pregnant woman

Ages Eligible for Study
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Minimum Age: 20 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 200 mg/m2/d in a fasting state for 5 consecutive days | Drug: Temozolomide<br>* Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle).<br>* Other names: Temodal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | PFS will be examined with Kaplan-Meier method. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | ORR will be evaluated through the frequency analysis with 95% confidence interval. | 1 year | 
| Overall survival (OS) | OS will be examined with Kaplan-Meier method. | 1 years | 
| progression-free survival (PFS) | PFS will be examined with Kaplan-Meier method. | 1 year | 
| Number of Participants with Adverse Events | Regarding safety endpoints, all adverse events will be individually graded based on the CTCAE version 4.03. The number of participants with adverse events will be summarized using descriptive statistics. | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temozolomide