Phase I, Open-Label Study With Dendritic Cell therapy (MesoPher) In Combination With Ex-tended-Pleurectomy/Decortication After Chemotherapy in Subjects With Resectable Mesothelioma.
- Conditions
- asbestos cancermalignant pleural mesothelioma10027412
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
• 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
treating
physician/Institution) and undergo a P/D with optional removal of hemidiaphragm
and
pericardium. The responsible surgeon and chest physician should judge the
required
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.
• 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
condition
that is likely to compromise the ability to give informed consent or to
interfere
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
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.
• 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
type I or
other conditions, where patient can be eligible following discussion with
medical
monitor.
• Subject who has received an organ allograft.
• 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 eP/D or
investigational
DCT.
•Unavailability of tumor tissue after completing chemotherapy and before
starting treatment with DCT.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the feasibility of DCT performed before and after eP/D in patients<br /><br>with early stage epithelioid MPM who received first line chemotherapy.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the safety of DCT performed before and after eP/D in patients with<br /><br>early stage epithelioid MPM.<br /><br>To evaluate the efficacy (as measured by progression free and overall survival)<br /><br>of combining DCT and eP/D after chemotherapy in patients with early stage<br /><br>epithelioid MPM.<br /><br>To determine the anti-tumor immune response induced by (neo)adjuvant DCT.</p><br>