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

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02629757
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Duration (Months): 97
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anaplastic Oligoastrocytoma; Anaplastic Astrocytoma; Glioblastoma	Drug: β-elemene	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study on β-elemene as Maintain Treatment for Complete Remission Patients of Newly Diagnosed Malignant Gliomas Following Standard Treatment
• Study Start Date: Apr 1, 2015
• Anticipated Primary Completion Date: Apr 1, 2020
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Over-all survival [5-year]

Secondary Outcome Measures

1. Quality of life [5-year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhongping Chen, Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT02629757
• Other Study ID Numbers: CSNO2015001
• First Posted: Dec 14, 2015
• Last Update Posted: Feb 23, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Zhongping Chen, Professor, Sun Yat-sen University: High-grade glioma; chemotherapy; β-elemene
• Additional relevant MeSH terms: Glioblastoma; Glioma; Astrocytoma

Study Results

No Results Posted as of Feb 23, 2018