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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma; Anaplastic Oligoastrocytoma; Anaplastic Astrocytoma
• Intervention / Treatment: Drug: β-elemene

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhong-ping CHEN; Phone Number: +86-20-87343310; Email: chenzhp@sysucc.org.cn
• Study Contact Backup: Name: Chengceng Guo; Phone Number: +86-20-87343890; Email: guochch@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Zhong-ping Chen; Phone Number: +86-20-87343310
      • Contact: Chengcheng Guo; Phone Number: +86-20-87343890

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: β-elemene; β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles.	Drug: β-elemene; β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Over-all survival	5-year

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life	5-year

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Zhong-ping CHEN, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 11, 2015
• First Posted (Estimate): December 14, 2015

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: chemotherapy; High-grade glioma; β-elemene
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Glioma; Astrocytoma
• Other Study ID Numbers: CSNO2015001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided