Multi-center, Randomized, Open-label Phase 3 Clinical Trial to Assess the Efficacy and Safety of 'INNOCELL Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 7
- 主要终点
- Progression-free Survival(PFS)
研究概览
简要总结
This clinical study was planned in order to assess the superiority of INNOCELL Corp. "Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Temozolomide to glioblastoma patients when compared with the control group who did not receive administration of the drug.
详细描述
<Primary Purpose> Compare clinical efficacy of group treated with cell theraputic INNOCELL Immuncell-LC evaluated by progression free survival with that of untreated group.
<Secondary Purpose> Compare clinical efficacy of group treated with INNOCELL Immuncell-LC, a drug for treating glioblastoma evaluated by overall survival, therapy reaction, EORTC QLQ-C30, and Karnofsky Performance Status (KPS) and that of untreated group, and evaluate adverse reactions, clinical pathological tests, and its safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who, prior to the study, received explanation of the purpose and content of study and of characteristics of the test drug from the test administrator and have consented to the study by providing signature of self, guardian, or legal representative.
- •Patients who are between 18 and 70 years of age
- •Patients whose cause of cancer has been found to be glioblastoma via pathological testing
- •patients who have received surgery for glioblastoma (Complete or partial extirpation or biopsy) 2 weeks prior to the study
- •Patients whose survival is expected to be longer than 3 months
- •Patients whose KPS is greater than 60
- •Patients who satisfy the following conditions of the blood test, kidney function test, and liver function test
- •Hemoglobin is bigger than 10 gm%
- •Platelet Count is bigger than 100,000/µL
- •Absolute granulocyte count is bigger than 1,500/µL
- •BUN or Creatinine 1.5 x upper normal limit
- •Bilirubin level is smaller than 2.0 mg/dL
- •SGOT, SGPT, alkaline phosphatase is smaller than 1.5 x upper normal limit
排除标准
- •Patients who have been determined to have serious Cardio - Pulmonary function disability by the clinical study staff
- •Patients who are immune deficient or have a history of auto immune diseases (Ex. Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.)
- •Patients who have a history of malignant tumors in the recent 5 years prior to the study with the exception of skin cancer, local prostate cancer, and cervical cancer.
- •Patients with history of severe allergies
- •Patients with serious mental illness
- •Patients who are pregnant or nursing
- •Patients who have participated in other clinical tests in the recent 4 weeks prior to the study
研究组 & 干预措施
Test Group
The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times).
干预措施: Activated T lymphocyte(Immuncell-LC) (Drug)
结局指标
主要结局
Progression-free Survival(PFS)
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months.
Progression-free survival was assessed locally by investigators on the basis of enhanced MRI was performed approximately 4 weeks after chemoradiotherapy, then at 10, 22, 34 and 46 weeks after randomization, and every 3\~12 months thereafter during the follow-up phase.
次要结局
- Overall Survival(OS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months.)