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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02416999
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hebei Yanda Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jisheng Wang, MDNan Ji, MD
Principal Investigator Affiliation Beijing Tiantan HospitalBeijing Tiantan Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent High-grade Glioma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Tiantan Hospital, Beijing, Beijing, China

Status

Not yet recruiting

Address

Beijing Tiantan Hospital

Beijing, Beijing, 100050

Site Contact

Nan Ji, MD

neurochina@gmail.com

+86 13910713896

Hebei Yanda Hospital, Sanhe, Hebei, China

Status

Not yet recruiting

Address

Hebei Yanda Hospital

Sanhe, Hebei, 065200

Site Contact

Nan Ji, MD

neurochina@gmail.com

+86 13910713896

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