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

Glioblastoma Clinical Trial

— ß-elemene  

Official title:

A Study on β-elemene as Maintain Treatment for Complete Remission Patients of Newly Diagnosed Malignant Gliomas Following Standard Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02629757
• Other study ID #: CSNO2015001
• Status: Recruiting
• Phase: Phase 3
• First received: December 10, 2015
• Last updated: February 21, 2018
• Start date: April 2015
• Est. completion date: May 2023

Study information

• Verified date: February 2018
• Source: Sun Yat-sen University
• Contact: Zhong-ping CHEN
• Phone: +86-20-87343310
• Email: chenzhp[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2023
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• - Page 3 of 4 [DRAFT] - Arms Assigned Interventions

• Temodar Experimental: temozolomide +a-IFN Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus a-IFN a-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: a-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

Related Conditions & MeSH terms

• Anaplastic Astrocytoma
• Anaplastic Oligoastrocytoma
• Astrocytoma
• Glioblastoma
• Glioma

Intervention

Drug:
• ß-elemene
ß-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Over-all survival		5-year
Secondary	Quality of life		5-year