JPRN-jRCT2063190013进行中（未招募）1 期
A phase I/IIa study of Ad-SGE-REIC-NS in patient with recurrent malignant glioma
Fujii Kentaro0 个研究点目标入组 18 人开始时间: 2019年8月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1) Has been histologically confirmed to be WHO grade 3 or 4, and recurrence or growth of tumor has been recognized in spite of standard treatment.
- •2) MRI brain image measured within 14 days prior to the administration of Ad-SGE-REIC-NS is more than 1.0cm both in major and minor axis.
- •3) Karnofsky Performance Scale (KPS) measured within 14 days prior to the administration of Ad-SGE-REIC-NS is 60% or more.
- •4) The patient's age upon enrollment is over 18 and under 80 years.
- •5) The administration of steroid (60mg equivalent of prednisolone) is allowed, but the dose should be stable within 7 days prior to the administration of Ad-SGE-REIC-NS.
- •6) Life expectancy should be more than 3 months.
- •7) The function of major organs should be normal and, in principle, the results of checkup examination conducted within 14 days prior to the administration of Ad-SGE-REIC-NS should fulfill the following criteria.
- •(1)Neutrophil >= 1.0 x 10^3/microL.
- •(2)Hemoglobin >= 9.0g/dL.
- •(3)Platelet >= 100 x 10^3/microL.
- •(4)Leucocyte>= 2.0 x 10^3/microL.
- •(5)AST/ALT < 4 times of upper limit of standard value
- •(6)PT-INR or APTT < 1.3 times of upper limit of standard value
- •(7)Creatinine <= 1.7mg/dL..
- •8) Must agree to use an acceptable method of birth control during the period of clinical study.
- •9) Willing and able to provide written informed consent prior to undergoing any study-specific procedures.
排除标准
- •1) Has received chemotherapy (other than gliadel wafer therapy), immunotherapy or any other therapy including investigational drug treatment and resection of glioma within 28 days prior to the administration of Ad-SGE-REIC-NS. When Temozolomide is prescribed, however, it can be administered until the day before the Ad-SGE-REIC-NS therapy starts.
- •2) Has received radiotherapy within 90 days prior to the administration of Ad-SGE-REIC-NS.
- •3) Has extracerebral metastasis or more than 2 extracerebral malignant glioma.
- •4) Has to be injected in brain ventricle or brain stem, or through brain ventricles.
- •5) Has subependymoma or subarachnoidal disseminated cancer.
- •6) Has considered other malignancies to be cured within 3 years.
- •7) Has contraindication to MRI examination, such as allergic reaction to MRI contrast media.
- •8) Has HBsAg antibody positivity, or HCV antibody or RNA positivity
- •9) Has HIV antibody positivityor with previous history of HIV.
- •10) Has active bacterial, fungal and virus infection (except for hepatitis B and C) or active double cancer.
- •11) Has a history of interstitial pneumonia.
- •12) Has a history of angina, heart failure or heart attack within 1 year.
- •13) Has a history of hypersensitivity to the test drug or any other drug used for the trial including pretreatment.
- •14) Has uncontrolled diabetes.
- •15) Requires immunosuppressive treatment except for systemic corticosteroid treatment.
- •16) Has a history of cerebritis, multiple sclerosis, central neurological infectious disease and addiction to alcohol or drugs, or has addiction to alcohol or drugs.
- •17) Women during pregnancy, women of childbearing potential or breast-feeding women.
- •18) Any patient judged inadequate to enroll in the trial by a doctor in charge.
研究者
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