Treatment with bevacizumab and irinotecan in patients with recurrent or refractory high grade glioma after conventional treatment. - ND

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点开始时间: 2009年5月27日最近更新: 2014年2月10日

适应症

试验速览

暂无简介。

•1.Histopathologic diagnosis of high grade glioma
•2.Evidence of recurrent or refractory high grage glioma after at least 1 conventional first line treatment
•3.Measurable disease by MRI
•4.Age > 14 years
•5.Karnofsky Performance Score ≥ 60%
•6.Life expectancy ≥ 3 months
•7.Intracranial surgery performed al least 6 weeks prior to entry
•8.No anticancer therapy (chemotherapy or radiotherapy) for at least 4 weeks (6 weeks for nitrosureas) prior to entry
•9.Haematology:
•a.Neutrophils ≥ 1.5 x 109/l
•b.Platelets ≥ 125 x 109/l
•c.Hematocrit > 29%
•10.Renal function: creatinina ≤1.5 mg/dL
•11.Liver function
•a.Bilirubin ≤ 1.5 mg/dL
•b.AST/ALT < 1.5 x normal upper limit
•12.Activated partial thromboplastin time (aPTT) < 1.5  normal upper limit in the absence of treatment with anticoagulation medications
•13.Contrast enhanced cranial MRI must have been performed within 3 weeks of study entry
•14.Dose of corticosteroid stable for at least 7 days before treatment initiation
•15.The pregnancy will not have to be started during treatment and for following 90 days
•16.Signed, informed consent
•Are the trial subjects under 18? yes
•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

•1.History of any other malignancy within 5 years (except non melanoma skin cancer or carcinoma in situ of the cervix)
•2.Other concomitant anticancer treatment
•3.Pregnant or nursing females
•4.Hemorrhage on baseline MRI of the brain
•5.Previous treatment with Bevacizumab
•6.Clinically significant cardiovascular diseases:
•History of myocardial infarction within 6 months prior to study registration
•New York Heart Association (NYHA) Grade II or greater heart failure
•Serious cardiac arrhythmia requiring medication
•Blood pressure of  150/100 mmHg in patient under treatment
•Unstable angina
•Clinically significant peripheral vascular disease
•7.History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 6 months prior to study registration
•8.Active inflammatory bowel disease or diverticulitis
•9.History of intracerebral abscess within 6 months prior to study registration
•10.Major surgical procedure, open biopsy, or significant traumatic injury within 14 days prior to study registration
•11.Minor surgical procedures, stereotactic biopsy, fine needle aspirations or core biopsies within 7 days prior to registration
•12.Serious non healing wound, active infection, ulcer, or bone fracture

发起方

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI