EUCTR2017-001690-16-NO进行中（未招募）1 期
Bortezomib sensitization of recurrent glioblastoma with unmethylated MGMT promoter to Temozolomide phase 1B/II study - BORTEM-17
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
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
- •All of the following conditions must apply to the prospective patient at screening prior to receiving study agent (e.g.):
- •?Histologically confirmed recurrent or progressed WHO grade IV intracranial glioblastoma (GBM), MRI evidence of recurrence within 14 days prior to enrolment
- •?Unmethylated MGMT promoter characterised from tissue obtained at operation
- •?Must submit an unstained paraffin block and cryopreserved tumour tissue from surgical procedure
- •?Must be >- 18 years old, with a life expectancy > 8 weeks
- •?Cranial MRI or contrast CT scan showing tumour relapse = 12 weeks since radiation treatment
- •?Measurable recurrent tumour
- •?Tumour not available for radiosurgery
- •?Written informed consent for study participation and tumour, blood sample collection obtained before performance of any study related procedure, and not part of normal medical care.
- •?Karnofsky performance status = 70%
- •?WBC = 3,000/mm^3
- •?ANC = 1,500/mm^3
- •?Platelet count = 100,000/mm^3
- •?Prothrombin time/international normalized ratio (PT INR) < 1.4.
- •?Haemoglobin = 10 g/dL (transfusion allowed)
- •?Bilirubin < 2.5 times upper limit of normal (ULN)
- •?Serum aspartate aminotransferase (AST); < 2.5 times ULN
- •?Adequate hepatic function: serum bilirubin = 1.5 x ULN, AST, ALT and alkaline phosphatase = 2.5 ULN,
- •?Serum potassium within normal limit
- •?Serum creatinine < 1.5 mg/dL
- •?Estimated GFR = 60
- •?Stable doses of corticosteroids for at least 1 week prior to enrolment, but analgesics and other drugs to treat symptoms or prevent complications allowed
- •?Patients receiving EIAED must be transitioned to non-EIAED at least 2 weeks before study inclusion
- •?Unfractionated and/or low molecular weight heparin is allowed
- •?Other investigational drugs must be discontinued at least 12 weeks prior to study entry
- •?Eligibility for standard therapy with Temozolomid as 5-days treatment q4w.
- •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 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •-hypersensitivity to Bortezomib, boron, or mannitol
- •-Peripheral neuropathy = grade 2
- •-Myocardial infarction within the past 6 months
- •-NYHA class III or IV heart failure
- •-Uncontrolled angina
- •-Severe uncontrolled ventricular arrhythmias
- •-LVEF = 45 % at echocardiography
- •-Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- •-serious medical or psychiatric illness that would interfere with study participation including, but not limited to, any of the following:
- •-Ongoing or active infection requiring IV antibiotics
- •-Psychiatric illness and/or social situations that would limit compliance with study requirements
- •-Ongoing, uncontrolled infection requiring IV antibiotics
- •-Disorders associated with a significant immunocompromised state (e.g., HIV, systemic lupus erythematosus)
- •-history of stroke within the past 6 months
- •-other malignancy within the past 3 years except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy (i.e., cervical cancer), or low-risk prostate cancer after curative therapy
- •-significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- •-disease that will obscure toxicity or dangerously alter drug metabolism
- •-viral hepatitis (HBV surface antigen positive) or active hepatitis C infection
- •-concurrent investigational drugs (chemotherapy) must be stopped at least 4 weeks prior to therapy.
- •-concurrent inducers of CYP450 3A4 (e.g., enzyme-inducing anti-epileptic drugs [EIAED] e.g. phenytoin, fosphenytoin, carbamazepine, phenobarbital, or primidone)
- •-Another ongoing experimental therapy
- •-Any contraindications for use of Temozolomid
研究者
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