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

Primary Purpose

Recurrent High-grade Glioma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ultra-low dose Bevacizumab
Temozolomide
Sponsored by
Hebei Yanda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent High-grade Glioma focused on measuring glioma, high-grade glioma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tiantan Hospital
  • Hebei Yanda Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patient group

Arm Description

Outcomes

Primary Outcome Measures

6-month survival rate of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
12-month survival rate of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment

Secondary Outcome Measures

Overall survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Overall survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Progression free survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Progression free survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment
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)
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)

Full Information

First Posted
April 1, 2015
Last Updated
February 17, 2016
Sponsor
Hebei Yanda Hospital
Collaborators
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02416999
Brief Title
Ultra-low Dose Bevacizumab Plus Temozolomide for Recurrent High-grade Gliomas
Official Title
Ultra-low Dose Bevacizumab Plus Temozolomide for Recurrent High-grade Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Yanda Hospital
Collaborators
Beijing Tiantan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent High-grade Glioma
Keywords
glioma, high-grade glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patient group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ultra-low dose Bevacizumab
Other Intervention Name(s)
BVZ
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
TMZ
Primary Outcome Measure Information:
Title
6-month survival rate of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Time Frame
6 months
Title
12-month survival rate of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Time Frame
6 months or later, up to 12 months
Title
Overall survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Time Frame
12 months or later, up to 24 months
Title
Progression free survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Time Frame
6 months or later, up to 12 months
Title
Progression free survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Time Frame
12 months or later, up to 24 months
Title
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)
Time Frame
6 months
Title
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)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Ji, MD
Phone
+86 13910713896
Email
neurochina@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jisheng Wang, MD
Phone
+86 15210503095
Email
neurowang@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jisheng Wang, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nan Ji, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Ji, MD
Phone
+86 13910713896
Email
neurochina@gmail.com
First Name & Middle Initial & Last Name & Degree
Jisheng Wang, MD
First Name & Middle Initial & Last Name & Degree
Nan Ji, MD
Facility Name
Hebei Yanda Hospital
City
Sanhe
State/Province
Hebei
ZIP/Postal Code
065200
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Ji, MD
Phone
+86 13910713896
Email
neurochina@gmail.com
First Name & Middle Initial & Last Name & Degree
Jisheng Wang, MD
First Name & Middle Initial & Last Name & Degree
Nan Ji, MD

12. IPD Sharing Statement

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

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