EUCTR2006-000182-10-DK进行中（未招募）不适用
A phase II trial with cetuximab, bevacizumab and irinotecan for patients with malignant glioblastomas and progression after radiation therapy and temozolamid - CBI-GBM
Rigshospitalet, Finsen Center0 个研究点目标入组 32 人开始时间: 2006年4月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
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 GBM.
- •Recurrence or progression after standard treatment (debulking surgery of possible, radiotherapy and temozolamide within last six months).
- •Evidence of measurable recurrent progressive primary GBM (CT/MRI scan).
- •An interval of at least 6 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).
- •Age 18-60.
- •Life expectancy > 3 month.
- •Normal organ function.
- •Fertile females must use oral contraceptive, IUD (intrauterine device) or preservatives. Fertile males must use preservatives.
- •No evidence of haemorrhage on baseline (CT/MRI scan).
- •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.
- •No hypercholesterolemia or hypertriglyceridemia (despite lipid-lowering therapy).
- •Any significant cardiac disease (New York Heart Association Class II or greater), arytmia, congestive heart failure, acute myocardial infaction 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 .
- •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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