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

NCT02629757 | Unknown Phase 3

• 1 other identifier: CSNO2015001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaplastic Oligoastrocytoma; Anaplastic Astrocytoma; Glioblastoma

Keywords

High-grade glioma; chemotherapy; β-elemene

Outcome Measures

Primary Outcomes (1)

• Over-all survival

  5-year

Secondary Outcomes (1)

• Quality of life

  5-year

Study Arms (1)

β-elemene

EXPERIMENTAL

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

Drug: β-elemene

Interventions

β-elemene DRUG

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

β-elemene

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Astrocytoma; Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Zhong-ping CHEN

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhong-ping CHEN

CONTACT

+86-20-87343310; chenzhp@sysucc.org.cn

Chengceng Guo

CONTACT

+86-20-87343890; guochch@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2023
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

CN (1)