EUCTR2006-006011-74-DK进行中（未招募）1 期
A phase II trial with bevacizumab and irinotecan for patients withprimary brain tumors and progression after standard therapy - BI-Brain-01
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •·Written informed consent
- •·Histological verification of primary malignant brain tumor, or grade II glioma, meningeoma or ependymoma with progression and no other treatment options (including brain stem gliomas without histological verification)
- •·Recurrence or progression after standard treatment (debulking surgery of possible, radiotherapy and temozolamide or other chemotherapy within last six months)
- •·Evidence of measurable recurrent progressive disease (CT/MRI scan)
- •·An interval of at least 4 weeks between prior surgical resection and study enrolment
- •·An interval of at least 4 weeks between prior radiotherapy or chemotherapy and enrolment on this protocol.
- •·PS 0-2 (ECOG scale)
- •·Life expectancy > 3 month
- •·Normal organ function:
- •- Platelets > 125 x 109/l
- •- Hemoglobin >6,2 mmol/l
- •- Leukocytes > 3 x 109/l
- •- ACN> 1,5 x 109/l
- •- ASAT or ALAT < 3 x upper normal limit
- •- Bilirubin < 1,5 x upper normal limit
- •- Creatinine clearance > 45 ml/min
- •- APTT < normal limit
- •- INR < normal limit
- •·Fertile females must use oral contraceptive, IUD (intrauterine device) or preservatives. Fertile males must use preservatives.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Radiotherapy or chemotherapy within the last 4 weeks.
- •·Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
- •·Any condition (medical, social, psychological), which would prevent adequate information and follow-up
- •·Any other active malignancy or previous malignancies within the last 5 years, except, adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ.
- •·Any significant cardiac disease (New York Heart Association Class II or greater), arytmia, congestive heart failure, acute myocardial infarction within 6 months or unstable angina pectoris.
- •·Clinically significant peripheral vascular disease
- •·Evidence of bleeding diathesis, coagulapathy or taking ASA, NSAIDs or clopidogrel
- •·Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0, anticipation of need for major surgical procedure during the curse of the study
- •·Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0
- •·History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 month prior to day 0
- •·History of known HIV, Hepatitis B and Hepatitis C negative
- •·Any ongoing infection, uncontrolled diabetes mellitus, serious non-healing wound, ulcer or bone fracture
- •·Pregnancy or breast feeding
- •·Requires therapeutic anti-coagulation
- •·Blood pressure > 150/100 mmHG
- •·Grade 2 or greater proteinuria
研究者
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