NCT00909558暂停1 期
A Phase I Open Label, Single Site, Safety and Efficacy Study of the Effects of Autologous Natural Killer and Natural Killer T Cell Immunotherapy on Malignant Disease
Envita Medical Center, Inc.2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2009年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Is there any measurable effect upon the underlying cancer as assessed by an increase or decrease in the tumor as measured from baseline using established criteria?
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of natural killer (NK) cell and natural killer T (NKT) cell-based autologous adoptive immunotherapy in subjects with metastatic, treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous cell lung cancer, pancreatic cancer, colon cancer or prostate cancer.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female not less than 18 years of age or over 80 years of age.
- •Life expectancy of ≥ 24 weeks as measured by the Eastern Cooperative Oncology Group (ECOG) performance status.
- •Subjects must present with one of the following disease pathologies: Breast Cancer, Glioma, Hepatocellular Cancer, Squamous Cell Lung Cancer, Pancreatic Cancer, Colon Cancer or Prostate Cancer
- •The pathology must be an assessable disease (measurable by CT scan or MRI) that is refractory to standard treatments (e.g., chemotherapy, radiation, etc.)
- •Negative for hepatitis B, hepatitis C, HIV, and CMV.
- •Subjects must present with leukocyte counts above 3,000/μL and platelet counts above 100,000/ μL.
- •Subjects must present with minimum hemoglobin levels of
- •If female, subject is surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), post menopausal (no menses >12 months), or using a high-efficiency method of contraception such as implant, injectable, combination oral contraceptive, intrauterine device (IUD) or sexual abstinence, or has a vasectomized partner.
- •If female of childbearing potential, subject is not pregnant, breast-feeding or planning a pregnancy during the study, and has a negative pregnancy test on screening visit.
- •Able to comprehend and sign an informed consent document and comply with the requirements of the study.
排除标准
- •No measurable malignant disease by CT scan or tumor markers.
- •Life expectancy of ≤ 24 weeks as measured by the Eastern Cooperative Oncology Group (ECOG) performance status.
- •Age of less than 18 years or over 80 years of age.
- •Documented/confirmed positive testing for hepatitis B, hepatitis C, HIV, or CMV.
- •Prior or current history of autoimmune disease.
- •Pregnant or lactating women.
- •Leukocyte count < 3,000 /μL prior to leukapheresis.
- •Platelet count < 100,000/μL prior to leukapheresis.
- •Hemoglobin levels below
- •PTT (prothrombin time) of < 12 seconds or > than 15 seconds.
- •aPTT (activated partial thromboplastin time) of < 25 seconds or > than 39 seconds.
- •Failure or refusal to sign informed consent for the study.
- •Culture fails to meet specifications for study.
- •Subject has any other medical condition that, in the opinion of the investigator, might significantly affect the ability to safely participate in the study or affect the conduct of the study.
结局指标
主要结局
Is there any measurable effect upon the underlying cancer as assessed by an increase or decrease in the tumor as measured from baseline using established criteria?
时间窗: 5 -15 Weeks
次要结局
- Are the dosages administered during the study safe, as measured by the number of unexpected and serious adverse events associated with the study drug, as defined by FDA regulations and as measured by established criteria?(5 - 15 weeks)
研究者
研究点 (2)
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