ISRCTN66517336已完成1 期
Dendritic cell-based immunotherapy in mesothelioma
Erasmus Medical Center, Department of Pulmonary Medicine (The Netherlands)0 个研究点目标入组 10 人开始时间: 2006年3月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
2005 results in: https://www.ncbi.nlm.nih.gov/pubmed/15764728 (added 14/02/2019) 2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20167848 (added 14/02/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with clinically and histologically or cytologically confirmed newly diagnosed mesothelioma, that can be measured in two dimensions by a radiologic imaging study
- •2. Patients must be at least 18 years old and must be able to give written informed consent
- •3. Patients must be ambulatory (Karnofsky scale =70, or World Health Organisation-Eastern Cooperative Oncology Group [WHO-ECOG] performance status 0,1, or 2) and in stable medical condition. The expected survival must be at least 4 months.
- •4. Patients must have normal organ function and adequate bone marrow reserve: absolute neutrophil count >1.5 x 10^9/l, platelet count >100 x 10^9/l, and Hb >6.0 mmol/l
- •5. Positive DTH skin test (induration >2 mm after 48 hours) against at least one positive control antigen of MULTITEST CMI (Pasteur merieux)
- •6. Stable disease or response after chemotherapy
- •7. Availability of sufficient tumor material of the patient
- •8. Ability to return to the Erasmus MC for adequate follow-up as required by this protocol
排除标准
- •1. Conditions that make the patient unfit for chemotherapy or progressive disease after 4 cycles of chemotherapy
- •2. Pleurodesis at the affected side before the pleural fluid is obtained
- •3. Medical or psychological impediment to probable compliance with the protocol
- •4. Patients on steroid (or other immunosuppressive agents) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation and must stop any such treatment during the time of the study
- •5. No prior malignancy is allowed except for 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
- •6. Serious concomitant disease, active infections. Patients with a history of autoimmune disease or organ allografts, or with active acute or chronic infection, including human immunodeficiency virus (HIV) (as determined by enzyme-linked immunosorbent assay [ELISA] and confirmed by Western Blot) and viral hepatitis (as determined by HBsAg and Hepatitis C serology).
- •7. Patients with serious intercurrent chronic or acute illness such as pulmonary (asthma or chronic obstructive pulmonary disease [COPD]) or cardiac (New York Heart Association [NYHA] class III or IV) or hepatic disease or other illness considered by the study coordinators to constitute an unwarranted high risk for investigational DC treatment
- •8. Patients with a known allergy to shell fish (contains keyhole limpet hemocyanin [KLH])
- •9. Pregnant or lactating women
- •10. Patients with inadequate peripheral vein access to perform leukapheresis
- •11. Concomitant participation in another clinical trial
- •12. 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
- •13. Absence of assurance of compliance with the protocol. Lack of availability for follow-up assessment.
研究者
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