Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Glioblastoma
Conditions
Keywords
High-grade glioma, chemotherapy, β-elemene
Brief summary
This study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma.
Detailed description
This study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma. β-elemene will be given 600mg/d,d1-14,q28 days for 6 cycles.
Interventions
DRUGβ-elemene
β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* \- Page 3 of 4 \[DRAFT\] - Arms Assigned Interventions * Temodar Experimental: temozolomide +α-IFN 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 dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days Other Names: • Temodar Drug: α-IFN 3mIU (3million) D1，3，5 Other Names: Minimum Age: 18 Years Maximum Age: 75 Years Gender: Both Accepts Healthy Volunteers?: No Criteria: Inclusion Criteria: * Age: 18 years to 75 years * complete remission patients of newly diagnosed WHO III-IV glioma following standard treatment * 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 * progression disease
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
Backup ContactChengceng Guo
Outcome results
None listed