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

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ClinicalTrials.gov Identifier: NCT02629757
Recruitment Status : Recruiting
First Posted : December 14, 2015
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Zhongping Chen, Sun Yat-sen University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Over-all survival [ Time Frame: 5-year ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 5-year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629757


Contacts
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Contact: Zhong-ping CHEN +86-20-87343310 chenzhp@sysucc.org.cn
Contact: Chengceng Guo +86-20-87343890 guochch@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China
Contact: Zhong-ping Chen    +86-20-87343310      
Contact: Chengcheng Guo    +86-20-87343890      
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Zhong-ping CHEN Sun Yat-sen University
More Information
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Responsible Party: Zhongping Chen, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02629757    
Other Study ID Numbers: CSNO2015001
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zhongping Chen, Sun Yat-sen University:
High-grade glioma
chemotherapy
β-elemene
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue