NCT04657315已完成1 期
Investigator-initiated and Open-labeled Clinical Trial for Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This is a phase I trial evaluating the maximum tolerated dose, safety and efficiency of Mesenchymal stem cells into which the suicide gene, cytosine deaminase (CD), injected into the resection cavity of patients with recurrent glioblastoma.
详细描述
Not Provided
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 to 70
- •Patients diagnosed with recurrent glioblastoma based on medical imaging after receiving standard therapy for glioblastoma
- •Patients scheduled to undergo surgical treatment for recurrent glioblastoma
- •Patients diagnosed with recurrent glioblastoma based on medical imaging (MRI: conventional, diffusion, perfusion, spectroscopy) and confirmed to have tumor cells during surgery based on frozen biopsy
- •Patients whose expected survival period is at least 3 months
- •Patients who have not received any other types of immunotherapy
- •Patients who have been given a sufficient explanation of the purpose and details of the clinical trial and the characteristics of the investigational drug from an investigator and who signed the consent form or had a legal guardian or representative sign the consent form prior to the beginning of this clinical trial
- •Patients who have waited for at least four weeks after treatment using cytotoxic drugs in order to eliminate the possibility of impact and effects from other therapeutic agents (23 days after the last administration in case of undergoing standard therapy using temozolomide)
排除标准
- •Patients who have primary glioblastoma
- •Patients with dihydropyrimidine dehydrogenase (DPD) deficiency
- •Patients who cannot undergo a contrast (gadolinium) enhanced MRI scan due to a certain condition (pacemaker, etc.) or cannot undergo an MRI scan according to the clinical trial schedule due to any other reasons
- •Patients to whom Gliadel water was applied during surgery
- •Patients who are deemed to have a serious dysfunction in any of the major organs (liver, kidneys, bone marrow, lungs, heart) by the investigator
- •Patents who have other types of malignant tumor aside from glioblastoma or who have had malignant tumor in the past 5 years
- •Patients who uncontrolled hypotension or hypertension
- •Diabetic patients who are currently receiving insulin therapy or who need insulin therapy
- •Patients who are deemed to have a serious infectious disease by the investigator: sepsis, hepatitis A, hepatitis B or hepatitis C (in the case of hepatitis B and C viruses, however, carriers may be enrolled at the investigator's discretion) or tested positive in a serological test for the human immunodeficiency virus (HIV)
- •Karnofsky Performance Scale < 60
- •Patients with an autoimmune disease affecting the central nervous system (multiple sclerosis, myasthenia gravis, acute disseminated encephalomyelitis, etc.)
- •Patients with a history of allergic reactions to flucytosine (5-FC) and/or its excipients or 5-fluorouracil (5-FU)
- •Pregnant or lactating women or patients who plan on getting pregnant during the clinical trial or refuses to choose an appropriate method of contraception
- •Patients who have participated in a different clinical trial no more than 30 days prior to registering for this clinical trial
- •Patients who are deemed to be unfit for this clinical trial by the investigator
研究组 & 干预措施
The investigational drug into the Intratumoral administration
Other
The investigational drug in the amount of 1x10^7, 3x10^7cells per dose into the tumor or the tumor removal site using a syringe during surgery
干预措施: MSC11FCD (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: after treatment discontinuation for approximately 1 years
Assessment of the maximum tolerated dose based on the 3+3 method * Blood concentrations of 5-FC and 5-FU(Day 1, Day 3, Day 7) * MSC11FCD concentrations (MSCCD detection) (Day 0, 3months, 6months, 12months)
Number Of Adverse Events related to the treatment
时间窗: Baseline, Day0, 1 month, 3 months, 6 months, 12 months
Evaluate the number of adverse event related to the treatment according to CTCAE V4.0 during the trial (including clinically significant changes in physical examination, radiographic images, safety lab tests, vital signs)
次要结局
- Overall Survival improvement (OS)(Study entry through the end of the study, up to 12 months)
- Progression Free Survival (PFS)(Study entry through the end of the study, up to 12 months)
- Tumor assessment in regard to the investigational drug based on the RANO criteria(At Baseline, 1month, 3months, 6months, 12months)
- Clinical efficacy assessment(At Baseline, 1month, 3months, 6months, 12months)
研究者
研究点 (1)
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