Clinical trial NCT02629757: A Study on β-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas
Official title: A Study on β-elemene as Maintain Treatment for Complete Remission Patients of Newly Diagnosed Malignant Gliomas Following Standard Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anaplastic Oligoastrocytoma
Anaplastic Astrocytoma
Glioblastoma
Keywords: High-grade glioma
chemotherapy
β-elemene
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Over-all survival
timeFrame: 5-year
Secondary outcomes:
measure: Quality of life
timeFrame: 5-year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhong-ping CHEN
role: PRINCIPAL_INVESTIGATOR
References: