Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Glioblastoma
Conditions
Keywords
High-grade glioma, chemotherapy, Temozolomide, Interferon-alpha
Brief summary
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
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.
Interventions
DRUGTemozolomide
dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days
DRUGα-IFN
3mIU (3million) D1，3，5
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Over-all survival | 5-year |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life | 5-year |
Countries
China
Contacts
Primary ContactZhong-ping CHEN, MD, PhD
Backup ContactCheng-cheng GUO, MD, PhD
Outcome results
None listed