NL-OMON37750撤回2 期
89Zr-RO5323441 PET imaging in patients with recurrent glioblastoma treated with bevacizumab - 89Zr-RO5323441 PET imaging in glioblastoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age >= 18 years;• WHO Performance status 0 - 2;• Histologically or biopsy proven glioblastoma at recurrence;• Patients treated with one line of systemic chemotherapy (combined treatment with temozolomide/ RT followed by 6 cycles of temozolomide is considered as one line of systemic chemotherapy).;• Adequate hematological functions: Neutrophils >= 1.5 x 109 cells/L, platelets >= 100 x 109 cells/L, Hb >= 6.2 mmol/L;• Adequate liver function: Bilirubin < 1.5 x upper limit of the normal range (ULN), alkaline phosphatase and transaminases (ASAT/ALAT) < 2.5 x ULN, INR < 1.5;• Adequate renal function:;- Serum creatinine increased * 3x ULN or/and Calculated (Cockcroft-Gault) or measured creatinine clearance > 30 mL/min;- Urine dipstick for proteinuria < 2+. Patients with >= 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hrs urine collection and must demonstrate <= 1 g of protein/24 hr;• Women of reproductive potential, female patients within one year of entering the menopause as well as males must agree to use an effective non-hormonal method of contraception during the treatment period and for at least 6 months after the last dose of bevacizumab;• Patients must be able to give written informed consent to participate.
排除标准
- •Last surgical procedure (including biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) < 28 days prior to start study treatment;• Current or recent (within 4 weeks of enrolment) treatment with another investigational drug or participation in another investigational study;• No radiotherapy within the 1 months prior to the diagnosis of progression;• No chemotherapy in the past 4 weeks;• Arterial or venous thrombosis <= 6 months prior to registration;• History of myocardial infarction (<= 6 months prior to inclusion), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring digoxin treatment;• Uncontrolled hypertension defined by a systolic blood pressure (BP) > 140 mm Hg and/or diastolic pressure > 100 mm Hg, with or without anti-hypertensive medication. Patients with initial blood pressure elevation are eligible if initiation or adjustment of anti-hypertensive medication lowers pressure to meet the entry criteria;• Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325 mg/day) or other NSAID with anti-platelet activity or treatment with dipyramidole, ticlopidine, clopidogrel and cilostaz;• Use of therapeutic-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes;• Clinically serious (as judged by the investigator) non-healing wounds, active skin ulcers or incompletely healed bone fracture;• Evidence of any active infection requiring hospitalization or antibiotics, within 2 weeks prior to day 1 of cycle 1;• Known hypersensitivity to any part of the bevacizumab formulation;• No geographical, psychological or other non-medical conditions interfering with follow-up;• Pregnant or lactating females. Serum pregnancy test to be assessed before entry in the trial
研究者
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