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Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma

Study Purpose

The purpose of this study is to determine whether bevacizumab and nimustine are effective in the treatment of recurrent high grade glioma and to explore whether there is any subgroup being sensitive to this therapeutic protocol.

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 - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histological diagnosis of primary tumor as high-grade gliomas (WHO III or IV) - All patients should complete radiotherapy and chemotherapy for primary gliomas.
  • - Enhanced MRI and magnetic resonance spectroscopy showed unequivocal evidence of tumor recurrence or progression.
  • - Those patients underwent surgical resection after tumor recurrence can also be enrolled if histological diagnosis of GBM is available, and MRI within 3 days after operation is needed.
  • - The patients with recurrent gliomas didn't undergo bevacizumab therapy before enrollment.
  • - The time to be enrolled should be more than 90 days after the radiation therapy, more than 28 days after operation for recurrent tumor or prior chemotherapy.
  • - Eastern Cooperative Oncology Group score: 0-2.
  • - Written informed consent.
  • - Laboratory test: Neutrophil count > 1.5*10^9/L, platelet count > 100*109/L, hemoglobin > 8 g/dL, blood urea nitrogen and creatinine < 1.5 upper limit of normal(ULN), blood total bilirubin and conjugated bilirubin < 1.5 ULN, alanine aminotransferase(ALT) and aspartate aminotransferase(AST) < 3 ULN, alkaline phosphatase(AKP) < 2 ULN.

Exclusion Criteria:

  • - Pregnant or lactating women.
  • - Allergic to administered drugs.
  • - Radiation therapy in the previous 90 days before enrollment.
  • - The patients with recurrent gliomas were treated with bevacizumab therapy before enrollment.
  • - Acute infection in need of antibiotics intravenously.
- Participation in other clinical trials in the 90 days before enrollment

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.

 NCT02698280
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.

 Phase 2
Lead Sponsor

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

 Huashan Hospital
Principal Investigator

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

 Yu Yao, MD, PhDDaoying Geng, MDXiaojie Ding, MDJianbo Wen, MD
Principal Investigator Affiliation Department of Neurosurgery, Huashan hospitalDepartment of Radiology, Huashan hospitalDepartment of Neurosurgery, Huashan hospitalDepartment of Radiology, Huashan hospital
Agency Class

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

 Other
Overall Status Completed
Countries China
Conditions

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

 Glioblastoma
Additional Details

Although anti-angiogenesis therapy for glioblastoma(GBM) are showing promise, GBMs often develop resistance to treatment within months or weeks after salvage therapy. There are still no effective markers to predict the response rate to bevacizumab. So the investigators initiate a single-arm Phase II study to evaluate the efficacy and tolerability of bevacizumab and nimustine regimen and to explore the predictive markers in patients with recurrent high-grade glioma.

Arms & Interventions

Arms

Experimental: Treatment

Patients are treated with bevacizumab and nimustine. Every 6 weeks is defined as one therapeutic cycle. Adverse effect is evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE; version 4.03). Hematologic toxicity is evaluated every 2 weeks. Liver function, renal function, and electrolytes are assessed every 4-6 weeks. Platelet should be no less than 100*10^9/L and neutrophil count should be no less than 1.5*10^9/L.

Interventions

Drug: - Bevacizumab

Bevacizumab is administered intravenously at 5mg/kg every 3 weeks.

Drug: - Nimustine

Nimustine is administered intravenously at 90mg/m^2 to 110mg/m^2 every 6 weeks.

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

Huashan hospital, Fudan University, Shanghai, Shanghai, China

Status

Address

Huashan hospital, Fudan University

Shanghai, Shanghai, 200040

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