Recurrent glioblastoma or anaplastic glioma after induction therapy
Conditions
Interventions
Bevacizumab + nimustine (ACNU) Bevacizumab: 10 mg/kg div, day 1, 15, 29 ACNU: 60 mg/m2 iv, day 1 in 42-day cycle, for 6 cycles. From 7th cycle, continue bevacizumab 10 mg/kg alone every 2 weeks.
Sponsors
Department of Neurosurgery, Kyorin University Faculty of Medicine
Department of Neurosurgery, The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age >= 20. 2) Expected to live more than 3 months. 3) Progressive or recurrent high-grade glioma documented by contrast MRI or CT (second or more recurrence is allowed) 4) Histologically proven diagnosis of glioblastoma or anaplastic glioma. 5) Prior treatment with TMZ and radiotherapy. 6) Patients who did not undergo surgery for recurrent disease must be enrolled within 14 days of the last radiological confirmation of progression with measurable lesions (diameter >= 0.5 cm) on contrast MRI or CT. Measurable lesions are not required for those who underwent surgery for recurrent disease. 7) Baseline contrast MRI or CT should be taken 1) 2 weeks or more after surgery (protocol treatment needs to be started after 28 days from surgery), 2) 5 days or more after fixation of corticosteroid dose. 8) No MRI evidence of acute or subacute cerebral hemorrhage at enrolment. Enrolment will, however, be permitted in the following cases: presence of hemosiderin; resolving hemorrhagic changes related to surgery at pre-enrolment MRI; and presence of punctuate hemorrhage in the tumor in the absence of clinical symptoms. 9) PS 0 - 2 at enrolment. PS 3 due to neurological deficits may be eligible. 10) Adequate laboratory data by the latest testing performed within 2 weeks prior to enrolment. 11) Written consent is obtained from the patient him/herself, or by his/her family members. 12) Patient who can be followed up.
Exclusion criteria
Exclusion criteria: 1) Active cancers in other organs. 2) Concurrent infectious diseases necessitate systemic treatment. 3) Patients who are pregnant, willing to be pregnant, within 28 days postpartum, or actively breastfeeding. 4) Male patients who will not prevent conception during protocol treatment. 5) Concurrent psychiatric disorders judged to be ineligible to enrolment. 6) Those under continuous systemic immunosuppressive treatment except for corticosteroids. 7) Those under treatment with continual use of insulin or with the complication of uncontrolled diabetes mellitus or peptic ulcer. 8) Evidence of unstable angina or history of cardiac infarction within 6 months. 9) Inadequately controlled hypertension at time of enrolment. 10) Current or prior hypertensive crisis or hypertensive encephalopathy. 11) New York Heart Association (NYHA) class II or greater congestive heart failure at enrolment. 12) History of symptomatic cerebrovascular disorder (including subarachnoid hemorrhage, cerebral infarction and transient ischemic attack) within 6 months prior to enrolment. 13) Current or history of vascular diseases (including venous/arterial thromboembolism, aortic aneurysms) requiring treatment within 6 months prior to enrolment. 14) History of grade >= 2 hemoptysis within 1 month prior to enrolment. 15) Hemorrhagic tendency (e.g., coagulation disorder) at enrolment or history of grade 3 or greater hemorrhagic events within 1 month prior to enrolment. 16) History of gastrointestinal perforation, fistula or abdominal abscess within 6 months prior to enrolment. 17) Concurrent pulmonary fibrosis, interstitial pneumonia, or high-grade emphysema. 18) Patients with severe non-healing wound or traumatic fracture at enrolment. 19) History of hypersensitivity to CHO-derived drugs or other recombinant antibodies. 20) HIV positive or HBV-Ag positive. 21) Those who are judged inappropriate for enrolment to this study by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 months progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, progression-free survival, complete response rate, overall response rate (ORR), adverse event rate, serious adverse event rate | — |
Countries
Japan
Contacts
Public ContactKeiichi Kobayashi
Kyorin University Faculty of Medicine Department of Neurosurgery
Outcome results
None listed