NL-OMON52279RecruitingNot Applicable
Phase I, Open-Label Study With Dendritic Cell therapy (MesoPher) In Combination With Ex-tended-Pleurectomy/Decortication After Chemotherapy in Subjects With Resectable Mesothelioma. - Ensure Trial
Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites16 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 16
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •Patients with a histologically confirmed diagnosis of epithelioid MPM who are
- •eligible for 2 to 4 cycles of platinum-based chemotherapy.
- •Patients must be at least 18 years old and must be able to give written
- •informed consent.
- •ECOG performance status 0-1.
- •Written informed consent according to ICH-GCP.
- •Fit to receive platinum-based chemotherapy (as per standard of care of the
- •physician/Institution) and undergo a P/D with optional removal of hemidiaphragm
- •pericardium. The responsible surgeon and chest physician should judge the
- •fitness prior to registration, taking into account the results of all the
- •relevant (i.e. pulmonary,
- •cardiac) examinations.
- •Tumor tissue available after completing chemotherapy and before starting
- •treatment with DCT. Tumor tissue can be obtained by either a CT-guided needle
- •biopsy or a VATS surgical biopsy.
Exclusion Criteria
- •Clinical or radiological invasion of mediastinal structures (heart, aorta,
- •spine, esophagus,
- •etc.) and widespread chest wall invasion (stage T4). Involvement of
- •supraclavicular
- •or coeliac nodes. Stage IV (metastatic disease).
- •Subject with any concurrent medical, psychological or psychiatric disease or
- •that is likely to compromise the ability to give informed consent or to
- •with study procedures or results, or that in the opinion of the investigator
- •would constitute
- •a hazard for participating in this study.
- •Subject with any previous malignancy except adequately treated basal cell or
- •cell skin cancer, superficial or in-situ cancer of the bladder or other cancer
- •which the subject has been disease-free for at least 3 years.
- •Subject with any known active serious infection, including human
- •immunodeficiency
- •virus (HIV), hepatitis B or C virus, or syphilis infection.
- •Subject with a history of autoimmune disease, except for diabetes mellitus
- •other conditions, where patient can be eligible following discussion with
- •Subject who has received an organ allograft.
- •Serious intercurrent chronic or acute illness such as pulmonary (COPD or
- •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 eP/D or
- •investigational
- •Unavailability of tumor tissue after completing chemotherapy and before
- •starting treatment with DCT.
Investigators
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