EUCTR2011-004974-27-NL进行中（未招募）不适用
89Zr-RO5323441 PET imaging in patients with recurrent glioblastoma treated with bevacizumab - 89Zr-RO5323441 PET imaging in glioblastoma
相关药物
试验速览
- 阶段
- 不适用
- 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
- •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.
- •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 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
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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