jRCT2033250552招募中不适用
A phase I clinical trial of a bevacizumab-expressing oncolytic herpesvirus T-BV in patients with malignant glioma
未提供0 个研究点目标入组 12 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients who have experienced tumor progression or recurrence following standard initial treatment for glioblastoma (IDH-wildtype) or grade 4 astrocytoma (IDH-mutant), and who meet all of the following criteria, will be eligible for inclusion in this study.
- •A confirmed histopathological diagnosis of glioblastoma (IDH-wildtype) or grade 4 astrocytoma (IDH-mutant) based on the WHO 2021 classification is required.
- •Patients who have experienced tumor progression or recurrence following standard initial treatment.
- •Patients with a confirmed lesion measuring >=1.0 cm on magnetic resonance imaging (MRI) performed within 14 days prior to the eligibility assessment date.
- •Patients with a Karnofsky Performance Status (KPS) of >=60% (or >=50% if the reduction is due to surgery-related paralysis).
- •The patient must be at least 18 years old at the time informed consent is obtained.
- •Patients who are capable of providing written informed consent themselves.
- •Maintain a constant steroid dosage for at least one week prior to Eligibility Determination Date.
- •Willing to use effective barrier birth control for at least 6 months after T-BV administration.
- •Expected survival >= 3 months.
- •Laboratory test results meet the following criteria
- •White blood cell count>2000/mm3, Absolute neutrophil count (ANC)>1000 /mm3, Platelets>100,000 /mm3, Hemoglobin>9.0 g/dL
- •Prothrombin time-international normalized ratio <= 1.3 times the upper limit of facility reference value
- •Serum creatinine<1.7mg/dL
- •AST and ALT <= 4 times the upper limit of facility reference value
- •Total bilirubin<=1.5 mg/dL
排除标准
- •Patients with a medical history or current condition of any of the following:
- •A history of encephalitis, multiple sclerosis, or other central nervous system infections
- •Known HIV seropositivity
- •Any contraindication for undergoing gadolinium contrast enhanced MRI such as: individuals with pacemakers, infusion pumps, or allergy to MRI contrast media
- •Patients in whom any of the following tumor conditions have been confirmed:
- •Extracranial metastasis of the tumor
- •Multiple (two or more) intracranial malignant glioma lesions
- •Tumors located in the ventricles, brainstem, or posterior fossa, or tumors requiring administration of the investigational drug via the ventricular route
- •Subependymal and subarachnoid dissemination
- •Patients with any of the following comorbidities:
- •Active herpesvirus infection
- •Herpesvirus infection requiring treatment with antiviral agents such as acyclovir, valacyclovir, famciclovir, vidarabine, or amenamevir
- •Active, uncontrolled infection that would interfere with the performance of surgery
- •Uncontrolled or severe medical condition such as heart failure, diabetes mellitus, hypertension, interstitial pneumonia, renal failure, and autoimmune disease
- •History of alcohol or other drug dependency
- •Other active cancer
- •Allergy to anti-HSV drug
- •Patients who have received any of the following treatments:
- •Administration of other clinical study drugs or research treatments within 30 days of T-BV administration
- •Surgical resection of a brain tumor within 30 days of T-BV administration
- •Bevacizumab within 30 days of T-BV administration
- •Prior gene therapy or oncolytic virus therapy other than T-BV
- •Pregnant or nursing females
- •Conditions considered inadequate for the subject to be enrolled in the study
研究者
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