An Open-label, Single-arm, Multicenter, Investigator-initiated Clinical Trial to Evaluate the Efficacy and Safety of Repeated Intratumoral Administration of Ad-SGE-REIC-NS in Patients with Recurrent Glioblastoma (REPETITION)

未提供0 个研究点目标入组 27 人开始时间: 待定

适应症

试验速览

阶段: 不适用
状态: 尚未招募
入组人数: 27

研究概览研究设计入排标准研究者记录与标识符相似试验

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: 20age old over 至 75age old under（—）
性别: All

入选标准

•Patients who have been diagnosed with glioblastoma according to the WHO Classification of Tumours, 5th Edition, based on a pathological diagnosis made prior to registration, regardless of whether the diagnosis was at initial presentation or at recurrence/progression.
•Glioblastoma patients at the time of first recurrence.
•Patients who, as initial treatment at first diagnosis, received postoperative chemoradiotherapy with concomitant temozolomide (>=54 Gy for patients aged <=69 years, and >=20 Gy for patients aged >=70 years), followed by at least two courses of adjuvant temozolomide maintenance therapy.
•Patients in whom at least 90 days have elapsed, as of the day of investigational product administration, since the date of the final radiation dose of radiotherapy administered concomitantly with temozolomide as specified in eligibility criterion 3).
•Patients who are not scheduled to receive temozolomide (TMZ) at the standard dose or to use Novo-TTF as prior treatment for glioblastoma on the day of investigational product administration.
•Patients who have at least one contrast-enhancing lesion on brain MRI performed within 14 days prior to the start of investigational product administration, with both the longest diameter and the shortest diameter measuring >=1.0 cm.
•Patients with a Karnofsky Performance Scale (KPS) score of >=60%, as assessed by the most recent evaluation performed within 14 days prior to the start of investigational product administration.
•Administration of corticosteroids up to a dose equivalent to prednisolone 60 mg/day is permitted; however, the steroid dose must have remained stable for at least 7 days immediately prior to investigational product administration.
•Patients with an expected life expectancy of at least 3 months.
•Patients aged >=20 years and <=75 years.
•Patients with adequate major organ function, for whom clinical laboratory values measured, in principle, within 14 days prior to the start of investigational product administration meet all of the following criteria:
•(1) Absolute neutrophil count >=1.0 x 10^3/uL
•(2) Hemoglobin concentration >=9.0 g/dL
•(3) Platelet count >=100 x 10^3/uL
•(4) White blood cell count >=2.0 x 10^3/uL
•(5) Hepatic transaminases (AST and ALT) <4 times the upper limit of normal (ULN)
•(6) PT-INR or APTT <1.3 times the upper limit of normal (ULN)
•(7) Serum creatinine concentration <=1.7 mg/dL
•Patients who have agreed to use appropriate contraceptive methods from the time of screening until 28 days after the final administration of the investigational product (for example, oral contraceptives, intrauterine contraceptive devices (IUD or IUS), condoms used in combination with spermicides, or condoms used in combination with a diaphragm).
•Patients who have been fully informed of the purpose and details of this clinical trial, the anticipated efficacy, pharmacological effects, and potential risks, and who have demonstrated adequate understanding thereof, and from whom written informed consent has been obtained voluntarily. However, if the patient is capable of understanding the information provided and giving consent but has difficulty signing due to neurological symptoms, a proxy may sign to confirm the patient's consent.

排除标准

•Patients who have a history of any of the following treatments as prior therapy for glioblastoma:
•(1) Drug therapy (e.g., bevacizumab). Temozolomide (TMZ) therapy at the standard dose, immunotherapy administered in combination with TMZ (including vaccine therapy, immune checkpoint inhibitors, antibody therapies, etc.), and placement of Gliadel wafers into the resection cavity at the time of surgery are permitted.
•(2) Viral or gene therapy products other than the investigational product (e.g., teserpaturev).
•(3) Stereotactic radiotherapy (e.g., Gamma Knife, CyberKnife).
•(4) Proton beam therapy.
•(5) Neutron capture therapy.
•Patients who, as prior therapy for glioblastoma, have received immunotherapy administered in combination with TMZ (including vaccine therapy, immune checkpoint inhibitors, antibody therapies, etc.) within less than 28 days prior to the start of investigational product administration.
•Patients with extracranial metastasis or with two or more glioblastoma lesions within the cranium, regardless of whether they are target or non-target lesions.
•Patients who require administration to the ventricles, brainstem, or posterior fossa, or patients in whom the administration site must be reached via the ventricular system.
•Patients with subependymal or leptomeningeal dissemination.
•Patients with a history of any of the following treatments for other malignancies: systemic chemotherapy, molecular targeted therapy, or radiotherapy to the head and neck region.
•Patients for whom MRI examination with contrast agent is contraindicated.
•Patients who are positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or RNA.
•Patients who are positive for HIV antibodies or have a history of HIV infection.
•Patients with active bacterial, fungal, or viral infections, excluding hepatitis B and hepatitis C.
•Patients with active multiple primary cancers, including synchronous multiple primary cancers or metachronous multiple primary cancers with a disease-free interval of less than 5 years. However, carcinoma in situ or lesions equivalent to intramucosal carcinoma that are considered cured by local treatment are not regarded as active multiple primary cancers.
•Patients with a history of interstitial pneumonia.
•Patients with angina pectoris, heart failure, or myocardial infarction for which one year has not elapsed since onset at the time of registration.
•Patients with symptomatic cerebrovascular disorders, including subarachnoid hemorrhage, cerebral infarction, and transient ischemic attack, or concomitant vascular disorders requiring treatment, including venous or arterial thrombosis or embolism and aortic aneurysm, or with a history of such conditions within 6 months prior to registration.
•Patients with a history of hypersensitivity to any drugs used in this clinical trial, including premedications.
•Patients with poorly controlled diabetes mellitus.
•Patients judged to be at high risk of suicidal ideation or suicidal behavior.
•Patients receiving immunosuppressive therapy, excluding systemic corticosteroids.
•Patients with a history of or concomitant encephalitis, multiple sclerosis, central nervous system infection, or alcohol or other substance abuse.
•Patients who are pregnant, breastfeeding, or wishing to become pregnant during the clinical trial period.
•Patients who are otherwise deemed inappropriate for participation in this clinical trial by the principal investigator or subinvestigator.

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