A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas

Study Overview
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Brief Summary
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This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma.

Detailed Description
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This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma. Four weeks after radiotherapy, newly diagnosed WHO III-IV glioma patients will be randomised into two groups: TMZ group or TMZ+ α-IFN groups.

Official Title
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A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas

Conditions
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Anaplastic Oligoastrocytoma, Anaplastic Astrocytoma, Glioblastoma

Intervention / Treatment
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* Drug: Temozolomide
* Drug: α-IFN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years to 75 years newly diagnosed WHO III-IV glioma after operation and radiotherapy Karnofsky Performance Score ≥ 60 Adequate bone marrow, liver and renal function Ability of subject to understand character and individual consequences of the clinical trial Written informed consent anticipating survival ≥2 months Exclusion Criteria: Refusal to participate the study Known hypersensitivity or contraindication to temozolomide Incompletely radiation Pregnant or lactating females Malignant tumor other than brain tumor Contraindicated for MRI examination Unable to comply with the follow-up studies of this trial Purulent and chronic infected wounds Uncontrolled psychotic disorders or epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: temozolomide<br>Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide (150 mg/m^2 daily on Days 1-5 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles) | Drug: Temozolomide<br>* dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days<br>* Other names: Temodar;|
| Experimental: temozolomide +α-IFN<br>Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN：3mIU (3million) Day1,3,5 of each 28 day TMZ：150 mg/m^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles | Drug: Temozolomide<br>* dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days<br>* Other names: Temodar;Drug: α-IFN<br>* 3mIU (3million) D1，3，5<br>* Other names: INTRONA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Over-all survival |  | 5-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 5-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-grade glioma, chemotherapy, Temozolomide, Interferon-alpha