A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas

Glioblastoma Clinical Trial

Official title:

A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01765088
• Other study ID #: CSNO2012001
• Status: Recruiting
• Phase: Phase 3
• First received: January 7, 2013
• Last updated: February 21, 2018
• Start date: September 2012
• Est. completion date: December 2019

Study information

• Verified date: February 2018
• Source: Sun Yat-sen University
• Contact: Zhong-ping CHEN, MD, PhD
• 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 the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma.

Description:

This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma. Four weeks after radiotherapy, newly diagnosed WHO III-IV glioma patients will be randomised into two groups: TMZ group or TMZ+ α-IFN groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age: 18 years to 75 years

• newly diagnosed WHO III-IV glioma after operation and radiotherapy

• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Temozolomide
dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days
• a-IFN
3mIU (3million) D1,3,5

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