Phase 2 study of bevacizumab in a fixed term for glioblastoma
- Conditions
- glioblastoma
- Registration Number
- JPRN-UMIN000026856
- Lead Sponsor
- Fujita Health University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Not provided
(1) Evidence of recent haemorrhage on postoperative MRI. (2) Any prior chemotherapy, radiotherapy or immunotherapy (including vaccine therapy) for glioma. (3) Prior radiotherapy to the brain. (4) Uncontrolled hypertension (systolic pressure >= 150, diastolic pressure >= 100). (5)Prior history of hypertensive crisis, or hypertensive encephalopathy. (6)Congestive heart failure (NYHA class III, or greater) (7)History of hemoptysis (Grade 2 or higher in CTCAE v4.0) within 1 month. (8) Coagulopathy (9) Uncontrolled gastrointestinal ulceration. (10) Serious or non-healing wound or traumatic bone fracture. (11) Past history within 6 months, as follows. Unstable angina, acute myocardial infarction, symptomatic cerebral infarction, arterial or venous thrombosis which required medical treatment, digestive tract perforation or abdominal fistula,intra-abdominal abscess, and intracranial abscess (12) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ (13) Pregnancy or lactation, as well as fertile women and men unwilling or unable to use effective means of contraception (14) Allergy to temozolomide, bevacizumab (15) Patients with allergy to gadolinium. (16) Patients registering other clinical trial. (17) Attending physician has determined unsuitable to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method