A Phase I/II Study to Assess the Safety and Efficacy of Vaccinations With Allogeneic Dendritic Cells: Autologous Tumor-Derived Cells Subjected to Electrofusions in Patients With AJCC Stage IV Renal Cell Carcinoma

Beth Israel Deaconess Medical Center1 个研究点分布在 1 个国家目标入组 40 人2002年12月1日

适应症Renal Cell Carcinoma

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Renal Cell Carcinoma
发起方: Beth Israel Deaconess Medical Center
入组人数: 40
试验地点: 1
主要终点: To assess the safety of 3 serial vaccinations with allogeneic DCs: autologous tumor-derived cells subjected to electrofusion in patients with AJCC stage IV RCC
状态: 已完成
最后更新: 3个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

This study will look how using taken from your tumors and mixed with special immune stimulating cells from another person's blood in given back to you in a series "fusion cell" injections, will effect your body. The primary goal of the study is to see if giving the experimental fusion cell injections is safe. We will also be looking to see what effect the experimental treatment as on your immune system and whether it has an effect on your cancer.

详细描述

Patients undergo tumor aquisition and short-term tumor cell cultures are established. Leukopheresis is performed monocyte-derived DC are generated ex-vivo by standard culture techniques, utilizing GM-CSF and Il-4. PEG fusions are generated, and following irradiation, the vaccine is frozen. The thawed vaccine is administered SC into a single site every three weeks. Each study is examining a dose-escalating strategy based apon the number PEG-fused generated from the PEG process that expressed both tumor cell and DC markers as determined by immune staining.

注册库

clinicaltrials.gov

开始日期

2002年12月1日

结束日期

2008年2月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Beth Israel Deaconess Medical Center

责任方

Principal Investigator

主要研究者

David Avigan

Professor of Medicine

Beth Israel Deaconess Medical Center

入排标准

入选标准

•The patient must be \_\> 18 years of age
•The patient must be diagnosed with AJCC stage IV (primary or relasped) RCC
•The patient must have a baseline Eastern Cooperative Oncology Group (ECOG) Clinical performance of 0-1
•The patient must have accessible tumor (minimum of 2.5cm in diameter in aggregate and accessible) for vaccine production
•The patient must have measurable tumor lesions (using Response Evaluation Criteria in Solid Tumors (RECIST) following resection of tumor lesions(s) used for vaccine production. If the patient has received previous radiation or intra-tumoral investigational treatments, the measurable disease must be outside the previous radiation port or treatment area unless there is documented tumor progression following the completion of therapy.
•The patient must have adequate hematologic, hepatic, and renal function parameters within 21 days prior to the first vaccination (day 0 of treatment):
•White blood cell(WBC) count \>\_ 3,000 cell/mm3
•Platelet count \>\_ 100,000 platelets/mm3
•Creatine(serum) \<2.0mg/dL
•Total bilirubin \<2.0 mg/dL

排除标准

•The patient has received prior chemotherapy
•The patient's tumor-derived cells do not meet predetermined manufacturing specifications, for example: human leukocyte antigen (HLA) Class 1 molecule expression, sufficient tumor derived cells for vaccine manufacture, or pathologic confirmation of RCC
•The patient has received more than 2 prior regimes for treatment of RCC and the most recent is within 2 weeks of the first screening procedure
•The patient has received radiation therapy within 2 weeks of the first sceeening procedure
•The patient has a clinically significant autoimmune diorder
•The patient has an active infection at the time of the first screening procedure requiring parenteral antibiotics
•The patient has clinically significant hematolgic, cardiac, renal, or hepatic disease or any other underlying condition that would contraindicate study therapy or confuse interpretation of study results
•The patient has any active or clinically significant central nervous system (CNS) metastases
•The patient has a previous unrelated malignancy or second malignancy within 5 years prior to the first screening procedure, except from non-melanoma skin cancer and in situ carcinomas
•The patient is receiving chronic immunosuppressive, and/or oral steriod treatment

结局指标

主要结局

To assess the safety of 3 serial vaccinations with allogeneic DCs: autologous tumor-derived cells subjected to electrofusion in patients with AJCC stage IV RCC

时间窗: screening/baseline, treatment period, follow-up and long-term follow-up

次要结局

To determine if 3 serial vaccinations of allogeneic DCs: autologous tumor-derived cells subjected to electrofusion will induce a clinical response as assessed by tumor response and will induce an immune response.(screening/baseline, treatment period, follow-up and long-term follow-up)