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Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698280
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaojie Ding, Huashan Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Bevacizumab Drug: Nimustine Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma
Actual Study Start Date : July 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
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.
Drug: Bevacizumab
Bevacizumab is administered intravenously at 5mg/kg every 3 weeks.
Other Name: Avastin

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




Primary Outcome Measures :
  1. All cause response to treatment [ Time Frame: 3 weeks ]
    Response will be evaluated according to the Response Assessment in Neuro-Oncology(RANO) criteria.Imaging Data (postcontrast T1W,T2/FLAIR),clinical symptoms and corticosteroid use will be collected in each participant and response assessment will be performed by one neurosurgeon and one neuroradiologist.


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: One year ]
  2. All cause disease progression [ Time Frame: 3 weeks ]
    Progression disease will be evaluated according to the RANO criteria

  3. All cause severe toxicities [ Time Frame: 3 weeks ]
    All toxicities will be assessed and graded according to CTCAE v4.03



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698280


Locations
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China, Shanghai
Huashan hospital, Fudan University
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Huashan Hospital
Investigators
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Study Chair: Yu Yao, MD, PhD Department of Neurosurgery, Huashan hospital
Study Chair: Daoying Geng, MD Department of Radiology, Huashan hospital
Principal Investigator: Xiaojie Ding, MD Department of Neurosurgery, Huashan hospital
Principal Investigator: Jianbo Wen, MD Department of Radiology, Huashan hospital
Publications:

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Responsible Party: Xiaojie Ding, Resident, Huashan Hospital
ClinicalTrials.gov Identifier: NCT02698280    
Other Study ID Numbers: KY-2015-289; 02
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Keywords provided by Xiaojie Ding, Huashan Hospital:
Bevacizumab
Nimustine
Pathology, Molecular
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Nimustine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors