NL-OMON48572已完成2 期
Adjuvant dendritic cell based immunotherapy (DCBI) after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal mesothelioma - MESOPEC
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
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
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •Patients with a histologically confirmed diagnosis of malignant peritoneal
- •mesothelioma
- •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 or 1) and in
- •stable medical condition
- •Patients must have normal organ function and adequate bone marrow reserve:
- •absolute neutrophil count >1.0 *109/l, platelet count >100*109/l and Hb
- •>6.0mmol/l
- •Ability to return to the study center for adequate follow-up and vaccinations
- •Positive DTH skin test (induration > 2mm after 48 hrs) against at least
- •one positive control antigen tetanus toxoid.
- •Written informed consent according to the ICH-GCP
- •Planned start date of vaccination within 8-10 weeks after CRS-HIPEC
- •The expected survival must be at least 6 months
- •Ability to return to the Erasmus MC for adequate follow-up as required by
- •this protocol
排除标准
- •4.3 Exclusion criteria A potential participant who meets any of the following
- •criteria will be excluded from participation in the study: • Extra-abdominal
- •disease/ metastatic disease • Medical or psychological impediment to probable
- •compliance with the protocol • Current use of steroids or other
- •immunosuppressive agents. Patients must have had six weeks of discontinuation
- •before the first vaccination and must stop any such treatment during the time
- •of the study on the basis of potential immune suppression. Prophylactic usage
- •of dexamethasone during chemotherapy is excluded from that 6 weeks interval. •
- •Prior cytoreductive surgery • Subject with any previous 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 subject has been
- •disease-free for at least 3 years or a malignancy that requires no active
- •treatment. • Serious concomitant disease or active infections • History of
- •auto-immune disease or organ allografts, or with active or chronic infection,
- •including HIV and viral hepatitis • Serious intercurrent chronic or acute
- •illness such as pulmonary (COPD or asthma) 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 CRS-HIPEC or investigational DC
- •treatment • 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 • Patients with a known allergy to shell fish (may contain KLH)
研究者
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