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