Ultra-low Dose Bevacizumab Plus Temozolomide for Recurrent High-grade Gliomas

Recurrent High-grade Glioma Clinical Trial

Official title:

Ultra-low Dose Bevacizumab Plus Temozolomide for Recurrent High-grade Gliomas

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02416999
• Other study ID #: YDCR-2015-001
• Status: Not yet recruiting
• Phase: N/A
• First received: April 1, 2015
• Last updated: February 17, 2016
• Start date: May 2015
• Est. completion date: May 2018

Study information

• Verified date: February 2016
• Source: Hebei Yanda Hospital
• Contact: Nan Ji, MD
• Phone: +86 13910713896
• Email: neurochina[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the effectiveness of ultra-low dose Bevacizumab plus Temozolomide for recurrent high-grade gliomas.

Description:

This trial is aimed at evaluating the effectiveness of ultra-low dose Bevacizumab plus Temozolomide for recurrent high-grade gliomas. And, this trial is approved by medical ethics committee of Hebei Yanda Hospital.Researchers will conduct thsi trial from 2015/05 to 2018/05, and 30 recurrent high-grade glioma patients will be recruited. Patients who are recruited will get treatment of ultra-low dose Bevacizumab plus Temozolomide in ether Hebei Yanda Hospital or Beijing Tiantan hospital, and get follow-ups from clinicians.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• High grade glioma was diagnosed by post-operation pathological method, and shows a relapse.

• Before included, the patient needs imageological examinations, and the diameter of contrast enhancing area is bigger than 1cm, PET or MRS results show positive features.

• The age of patient should be between 18 years old and 70 years old.

• The condition of the patient permits the treatment of ultra-low dose Bevacizumab plus Temozolomide.

• The patient is informed consent,and willing to join in this research.

Exclusion Criteria:

• The diagnosis is not recurrent high-grade glioma.

• The diagnosis of high-grade glioma was not established by pathological method.

• The results of imageological examinations do not meet the standard of including.

• The age of the patient does not meet the requirement of this research.

• The condition of the patient does not permit the treatment of ultra-low dose Bevacizumab plus Temozolomide.

• There are other conditions that the clinicians believe that the treatment of ultra-low dose Bevacizumab plus Temozolomide is not appropriate for the patient.

• The patient is not willing to join in this research.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma
• Recurrent High-grade Glioma

Intervention

Drug:
• Ultra-low dose Bevacizumab

• Temozolomide

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing
China	Hebei Yanda Hospital	Sanhe	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Hebei Yanda Hospital	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month survival rate of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment		6 months	No
Primary	12-month survival rate of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment		12 months	No
Secondary	Overall survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment		6 months or later, up to 12 months	No
Secondary	Overall survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment		12 months or later, up to 24 months	No
Secondary	Progression free survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment		6 months or later, up to 12 months	No
Secondary	Progression free survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment		12 months or later, up to 24 months	No
Secondary	6-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30 and EORTC QLQ-BN20 together)		6 months	No
Secondary	12-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30 and EORTC QLQ-BN20 together)		12 months	No