NL-OMON45421撤回2 期
Autologous Dendritic Cells Loaded with Allogenic Tumor Lysate for Surgically Resected Pancreatic Cancer Patients (REACtiVe Trial)<br> - Rotterdam pancrEAtic Cancer Vaccination Trial (REACtiVe Trial)
Stichting Leveronderzoek0 个研究点目标入组 26 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •* Surgically resected pancreatic cancer
- •* Completed post-operative standard treatment
- •* No disease activity assessed by radiological imaging
- •* Patients must be at least 18 years old and must be able to give written informed consent.
- •* Patients must be ambulatory (WHO-ECOG performance status 0,1, or 2)
- •* Patients must have normal organ function and adequate bone marrow reserve: absolute neutrophil count > 1.0 x 109/l, platelet count > 100 x 109/l, and Hb > 6.0 mmol/l. (as determined during screening)
- •* Positive DTH skin test (induration > 2mm after 48 hrs) against at least one positive control antigen tetanus toxoid.
- •* Ability to return to the hospital for adequate follow-up as required by this protocol.
- •* Written informed consent according to ICH-GCP
排除标准
- •* Medical or psychological impediment to probable compliance with the protocol.
- •* Previous or current treatment with immunotherapeutic agents..
- •* Current use of steroids (or other immunosuppressive agents). Patients must have had 6 weeks of discontinuation and must stop of any such treatment during the time of the study. Prophylactic usage of dexamethasone during chemotherapy is excluded from that 6 weeks interval
- •* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the patient has been disease-free for five years.
- •* Serious concomitant disease, or active infections.
- •* History of autoimmune disease or organ allografts, or with active acute or chronic infection, including HIV and viral hepatitis.
- •* Serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinator to constitute an unwarranted high risk for investigational DC treatment.
- •* Known allergy to shell fish (may contain KLH).
- •* Pregnant or lactating women.
- •* Inadequate peripheral vein access to perform leukapheresis
- •* Concomitant participation in another clinical trial
- •* An organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent, and preclude participation in the full protocol and follow-up.
- •* Absence of assurance of compliance with the protocol. Lack of availability for follow-up assessment.
研究者
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