EUCTR2008-003679-40-DK进行中（未招募）不适用
A phase II study of temsirolimus and bevacizumab in recurrent glioblastoma multiforme
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 and failure after radiotherapy and temozolomide (TMZ) previously treated with VEGF-directed therapy with bevacizumab
- •-Previously received radiotherapy and temozolomide
- •-More than 4 weeks since any of the following prior treatments:
- •a: Chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- •b: Radiotherapy to nontarget lesions or lesions that are not to be biopsied
- •c: VEGF-directed therapy (including bevacizumab)
- •d: Investigational agents
- •-More than 6 months since prior major surgery or open biopsy and recovered (only 6 weeks required if operation is for recurrent GBM)
- •-No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of the following (with exception to enzyme-inducing anti-epileptic drugs, please see dosage adjustment for temsirolimus page 10):
- •a: Temsirolimus
- •b: Bevacizumab
- •c: CYP450 isoenzymes
- •-ECOG performance status 0-1
- •-WBC = 3,000 mm³
- •-Absolute neutrophil count = 1,500/mm³
- •-Platelet count = 100,000/mm³
- •-Bilirubin normal
- •-AST and ALT = 2.5 times upper limit of normal
- •-Creatinine normal OR creatinine clearance = 60 mL/min
- •-Urine protein:creatinine ratio < 1.0 OR 24-hour urine protein < 1,000 mg
- •-Fasting cholesterol < 350 mg/dL (cholesterol medications are allowed)
- •-Fasting triglycerides < 400 mg/dL
- •-PT INR = 1.5
- •-Hematocrit < 41% (for males) or < 38% (for females)
- •-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
- •Clinically significant cardiovascular disease, including the following:
- •-Cerebrovascular accident within the past 6 months
- •-Transient ischemic attack within the past 6 months
- •-Myocardial ischemia within the past 6 months
- •-Myocardial infarction within the past 6 months
- •-Other thromboembolic event within the past 6 months
- •-Unstable angina within the past 6 months
- •-Uncontrolled hypertension (i.e., hypertension despite maximal therapy)
- •-New York Heart Association class II-IV heart disease
- •-Congestive heart failure
- •-Serious cardiac arrhythmia requiring medication
- •-Clinically significant peripheral vascular disease
- •-Uncontrolled intercurrent illness
- •-Ongoing or active infection
- •One of the following within the past 6 months:
- •a: Abdominal fistula
- •b. astrointestinal perforation
- •c: Intra-abdominal abscess
- •d Serious or nonhealing wound, ulcer, or bone fracture
- •-Psychiatric illness or social situations that would preclude study compliance
- •-Uncontrolled diabetes
- •-Hemoglobin A1c > 7%
- •-Concurrent nonstudy-related surgical procedures
- •-Other concurrent anticancer agents or therapies
- •-Significant traumatic injury within the past 28 days
- •-History of allergic reactions to compounds of similar chemical or biological composition to temsirolimus or bevacizumab
- •-Hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (e.g., infliximab)
- •-Pregnancy or nursing
- •-Patients previously intolerant to bevacizumab
- •-Anticoagulant therapy
研究者
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