Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma

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Fudan University

Status and phase

Completed
Phase 2

Conditions

Glioblastoma

Treatments

Drug: Nimustine
Drug: Bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT02698280
KY-2015-289 02;

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

Treatment
Experimental group
Description:
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.
Treatment:
Drug: Bevacizumab
Drug: Nimustine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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