NCT00776295终止2 期
Phase II Trial of Autologous Peripheral Blood Hematopoietic Cell Transplantation (PBHCT) Followed by Dendritic Cell p53 Vaccination and Adoptive T Cell Transfer in Patients With Limited Stage Small Cell Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Subjects Meeting 1-year Overall Survival
研究概览
简要总结
The purpose of this study is to determine whether p53 vaccination followed by high dose chemotherapy and autologous HCT and T cell therapy significantly induces immune responses resulting in 1-year survival greater that the current 70%.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed SCLC who presented with Limited Stage (LS) at diagnosis.
- •Measurable disease at the time of initial therapy
- •Appropriate treatment for LS-SCLC including radiotherapy and chemotherapy.
- •Responsive disease to standard chemoradiation therapy as defined by RECIST
- •Patients with CR after chemoradiation therapy are strongly recommended to be treated with prophylactic cranial irradiation
- •CBC with an absolute neutrophil count (ANC) >/= 1,000/uL, hemoglobin >/= 8.0 g/DL and platelet count >/= 75,000/uL.
- •Normal prothrombin time (PT) and partial thromboplastin time (aPTT), unless on monitored anticoagulation therapy for medical conditions not excluded in the trial.
- •Liver enzymes: total bilirubin less than or equal to 2mg/dL; AST and ALT less than 1.5X the upper limit of normal.
- •Creatinine clearance of >/= 60 mL/min
- •Pulmonary: DLCO greater than 50%
- •Cardiac: left ventricular ejection fraction greater than 45%
排除标准
- •Patient with stable (SD) or progressive disease (PD) after 4 cycles of standard cisplatin and etoposide and concurrent chest irradiation
- •Pregnant or lactating woman
- •HIV infection confirmed by NAT
- •Common variable immunodeficiency
- •Active CNS malignancy
- •Active bacterial, fungal or viral infection
- •Unfavorable psychosocial evaluation or history of poor compliance to prescribed medical care
- •Prior history of autologous or allogeneic hematopoietic cell transplantation
- •Presence of protocol specific comorbid conditions
研究组 & 干预措施
adeno virus vectored p53
Experimental
Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
干预措施: Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes (Biological)
结局指标
主要结局
Number of Subjects Meeting 1-year Overall Survival
时间窗: up to one year
Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death
次要结局
- 3 Year Progression-free Survival(up to 3 years)
研究者
研究点 (1)
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