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

Hebei Yanda Hospital

Status: Unknown

Conditions: Recurrent High-grade Glioma

Treatments: Drug: Temozolomide; Drug: Ultra-low dose Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02416999

YDCR-2015-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

patient group

Experimental group

Treatment:

Drug: Ultra-low dose Bevacizumab

Drug: Temozolomide