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

February 17, 2016 updated by: Hebei Yanda Hospital
This study is to evaluate the effectiveness of ultra-low dose Bevacizumab plus Temozolomide for recurrent high-grade gliomas.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Tiantan Hospital
        • Contact:
        • Principal Investigator:
          • Jisheng Wang, MD
    • Hebei
      • Sanhe, Hebei, China, 065200
        • Hebei Yanda Hospital
        • Contact:
        • Principal Investigator:
          • Jisheng Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient group
Drug: Temozolomide
Other Names:
  • TMZ
Drug: Ultra-low dose Bevacizumab
Other Names:
  • BVZ

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months or later, up to 12 months
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
12 months or later, up to 24 months
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
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
Time Frame: 12 months or later, up to 24 months
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)
Time Frame: 6 months
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)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Yanda Hospital

Collaborators

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Jisheng Wang, MD, Beijing Tiantan Hospital
  • Principal Investigator: Nan Ji, MD, Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

April 10, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YDCR-2015-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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