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Completed

NCT Number: NCT02698280

Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma

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.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Huashan hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

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

Other names: Avastin

Nimustine

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

Phase II Study of Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2016
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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