Adjuvant dendritic cell based immunotherapy (DCBI) after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal mesothelioma
- Conditions
- asbestos cancerperitoneal mesenthelioma10027412
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The aim of this phase II study is to determine the feasibility of adjuvant DCBI<br /><br>with injection of MesoPher in patients with MPM after CRS-HIPEC.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoint of this study is safety of this therapy, which has already<br /><br>been proven in patients with pleural mesothelioma. Another secondary endpoint<br /><br>is the determination of an immunological response against the tumor as result<br /><br>of the adjuvant therapy.</p><br>