| General information |
| Database: | DB00613 |
| Objective: | This singlearm, openlabel, phase II study evaluated the efficacy and safety of singleagent bevacizumab, a monoclonal antibody against vascular endothelial growth factor, in Japanese patients with recurrent malignant glioma. |
| Authors: | Nagane M, et al |
| Title: | Phase II study of singleagent bevacizumab in Japanese patients with recurrent malignant glioma. |
| Journal: | Jpn J Clin Oncol |
| Year: | 2012 |
| PMID: | 22844129 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | Tumors of the nervous system |
| Cancer Subtype: | glioblastoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | singlearm, openlabel, phase II study |
| Key Patients Feature: | aged 20 years with histologicallyconfirmed GBM or World Health Organization (WHO) GradeIII glioma, the latter being reconfirmed at the time of surgeryfor recurrent glioma. Patients had magnetic resonanceimaging (MRI)confirmed disease recurrence or progressionwith measurable lesions within 2 weeks prior to the first studytreatment and no evidence of acute or subacute cerebral hemorrhage and had received prior TMZ and RT for malignantglioma. Other key inclusion criteria were a Karnofsky performance status (KPS) 70%, a life expectancy of 3months and adequate hematologic, renal and hepatic function(i.e. absolute neutrophil count 1500/mm3, platelet count 100 000/mm3, hemoglobin 10 g/dl, bilirubin 1.5 theupper limit of normal (ULN), aspartate aminotransferase andalanine aminotransferase 2.5 ULN, serum creatinine 1.25 ULN). The following minimum intervals of time musthave elapsed between the termination of therapies and thestart of bevacizumab treatment: RT 8 weeks; surgical therapyand incisional biopsy 4 weeks; endocrine therapy and immunotherapy 3 weeks; posttraumatic intervention (except forpatients with nonhealing wounds) 2 weeks; transfusion andthe use of hematopoietic growth factors 2 weeks; aspirationcytology and needle biopsy 1 week; nitrosoureas 6 weeks, procarbazine 3 weeks, vincristine 2 weeks and other chemotherapies 4 weeks and other investigational new drugs andunapproved drugs 4 weeks |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts previously treated with temozolomide plus radiotherapy, received 10 mg/kg bevacizumab intravenous infusion every 2 weeks. |
| Primary End Point: | 6month progression free survival |
| Secondary End Point: | NA |
| Patients Number: | 31 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | There were eight responders (all partial responses) giving an objective response rate of 27.6%. The disease control rate was 79.3%. |
| Disease Control Rate: | 0.793 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.3 months. |
| Median OS A vs. C: | 10.5 months. |
| Adverse Event(agent arm): | Bevacizumab was welltolerated and Grade 3 adverse events of special interest to bevacizumab were as follows: hypertension [3 (9.7%) patients], congestive heart failure [1 (3.2%) patient] and venous thromboembolism [1 (3.2%) patient]. One asymptomatic Grade 1 cerebral hemorrhage was observed, which resolved without treatment. |
| Conclusions: | Singleagent bevacizumab provides clinical benefit for Japanese patients with recurrent glioblastoma. |