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

NCT ID: NCT02416999

Last Updated: 2016-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-05-31

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.

Conditions

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Recurrent High-grade Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patient group

Group Type EXPERIMENTAL

Ultra-low dose Bevacizumab

Intervention Type DRUG

Temozolomide

Intervention Type DRUG

Interventions

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Ultra-low dose Bevacizumab

Intervention Type DRUG

Temozolomide

Intervention Type DRUG

Other Intervention Names

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BVZ TMZ

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Hebei Yanda Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jisheng Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Nan Ji, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status

Hebei Yanda Hospital

Sanhe, Hebei, China

Site Status

Countries

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China

Central Contacts

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Nan Ji, MD

Role: CONTACT

+86 13910713896

Jisheng Wang, MD

Role: CONTACT

+86 15210503095

Facility Contacts

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Nan Ji, MD

Role: primary

+86 13910713896

Nan Ji, MD

Role: primary

+86 13910713896

Other Identifiers

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YDCR-2015-001

Identifier Type: -

Identifier Source: org_study_id

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