Combination of bevacizumab plus nimustine in patients with post-temozolomide recurrent or progressive high-grade glioma
- Conditions
- Recurrent glioblastoma or anaplastic glioma after induction therapy
- Registration Number
- JPRN-UMIN000018261
- Lead Sponsor
- Department of Neurosurgery, Kyorin University Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 32
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method