A Study on β-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas

Phase 3

• Conditions: Anaplastic Oligoastrocytoma; Anaplastic Astrocytoma; Glioblastoma
• Interventions: Drug: β-elemene

• Registration Number: NCT02629757
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-14
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-23
• Primary Completion: 2020-04
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
β-elemene	β-elemene	β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles.

Primary Outcome Measures

Name	Time	Method
Over-all survival	5-year

Secondary Outcome Measures

Name	Time	Method
Quality of life	5-year

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China