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

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

Detailed Description
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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.

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

Conditions
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Recurrent High-grade Glioma

Intervention / Treatment
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* Drug: Ultra-low dose Bevacizumab
* Drug: Temozolomide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient group<br> | Drug: Ultra-low dose Bevacizumab<br> <br> * Other names: BVZ;Drug: Temozolomide<br> <br> * Other names: TMZ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month survival rate of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment |  | 6 months | 
| 12-month survival rate of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment |  | 6 months or later, up to 12 months | 
| Overall survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment |  | 12 months or later, up to 24 months | 
| Progression free survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment |  | 6 months or later, up to 12 months | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glioma, high-grade glioma