asbestos cancer mesothelioma
Conditions
Interventions
Patients will be injected with autologuous dendritic cells which are generated
from monocytes obtainend from the patient via leucapheresis.
Patients will be injected both intravenously and intraderma
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The study population consists of adult patients with malignant mesothelioma who have been or have not been treated with chemotherapy. Patients treated with chemotherapy must not experience progressive disease during chemotherapy. In selected cases with low disease burden as determined by the multidisciplinary tumor board of Erasmus MC Rotterdam, patients can be included after diagnosis before any treatment.
Exclusion criteria
Exclusion criteria: patients with mesothelioma progressive after chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this phase I protocol is to study the toxicity and safety of AlloDen (DC-based immunotherapy) in MM patients. Toxicities will be scored according to CTC criteria version 4.0. The following toxicities occurring during 8 weeks after the first vaccination, will be considered as dose-limiting (DLTs): Hematological: Thrombocytopenia grade 3 during longer then 7 days or grade 4 Neutropenia grade 3 during longer then 7 days or grade 4 Non-hematological: Any grade 3/4 toxicity except for diarrhea, nausea, vomiting, hypertension if not adequately treatable, skin toxicity. Immune related: Any grade 4 except for rash and (drug related) fever | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end-points include the establishment of an immune response against tumor asscoiated antigens and the model antigen KLH. Read-out parameters are the side effects, immune responses, anti-tumor response and survival of this DC-based immunotherapy* both in vivo and in vitro. | — |
Countries
Netherlands
Outcome results
None listed