Malignant Pleural Mesothelioma
Conditions
Brief summary
Safety will be assessed by clinical laboratory tests and adverse event reporting: (1) Microbiological testing (bacteria, fungi, mycoplasma, endotoxin) will be performed to assess safe DC vaccine production, (2) Local toxicity (e.g. skin reactions at injection site) will be reported, (3) Systemic toxicity will be scored according to the latest version of the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) and Common Toxicity Criteria (CTC), Feasibility will be assessed based on the success of (1) leukapheresis and (2) DC vaccine preparation (production of at least 4 DC vaccines) and (3) administration of combined chemoimmunotherapy cycles within the proposed time schedule
Detailed description
Clinical endpoints: time to progression (TTP), progression-free survival (PFS) and overal survival (OS) (Tumor assessment will be performed according to the latest modified Response Evaluation Criteria In Solid Tumors (RECIST), PET Response Criteria In Solid Tumors (PERCIST) and endpoints for cancer immunotherapy trials), Translational endpoint: immunological responses (Systemic and local immunological response analysis will be performed to determine the in vivo immunogenicity of WT1 mRNA-electroporated DC vaccinations when combined with chemotherapy for the frontline treatment of MPM by evaluating the development of effective anti-mesothelioma immunity)
Interventions
DRUGWT1 LAMP mRNA DC
Sponsors
Antwerp University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be assessed by clinical laboratory tests and adverse event reporting: (1) Microbiological testing (bacteria, fungi, mycoplasma, endotoxin) will be performed to assess safe DC vaccine production, (2) Local toxicity (e.g. skin reactions at injection site) will be reported, (3) Systemic toxicity will be scored according to the latest version of the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) and Common Toxicity Criteria (CTC), Feasibility will be assessed based on the success of (1) leukapheresis and (2) DC vaccine preparation (production of at least 4 DC vaccines) and (3) administration of combined chemoimmunotherapy cycles within the proposed time schedule | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical endpoints: time to progression (TTP), progression-free survival (PFS) and overal survival (OS) (Tumor assessment will be performed according to the latest modified Response Evaluation Criteria In Solid Tumors (RECIST), PET Response Criteria In Solid Tumors (PERCIST) and endpoints for cancer immunotherapy trials), Translational endpoint: immunological responses (Systemic and local immunological response analysis will be performed to determine the in vivo immunogenicity of WT1 mRNA-electroporated DC vaccinations when combined with chemotherapy for the frontline treatment of MPM by evaluating the development of effective anti-mesothelioma immunity) | — |
Countries
Belgium
Outcome results
None listed