A phase I study on Dendritic cells loaded with allogeneous cell lysate (Alloys) in patients with mesothelioma as maintenance treatment (AlloDen)
Not yet recruiting
- Conditions
- asbestos cancermesothelioma10027412
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 18
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
patients with mesothelioma progressive after chemotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The aim of this phase I protocol is to study the toxicity and safety of AlloDen<br /><br>(DC-based immunotherapy) in MM patients. Toxicities will be scored according to<br /><br>CTC criteria version 4.0. The following toxicities occurring during 8 weeks<br /><br>after the first vaccination, will be considered as dose-limiting (DLTs):<br /><br><br /><br>Hematological:<br /><br>Thrombocytopenia grade 3 during longer then 7 days or grade 4<br /><br>Neutropenia grade 3 during longer then 7 days or grade 4<br /><br><br /><br><br /><br>Non-hematological:<br /><br>Any grade 3/4 toxicity except for diarrhea, nausea, vomiting, hypertension if<br /><br>not adequately treatable, skin toxicity.<br /><br><br /><br>Immune related:<br /><br>Any grade 4 except for rash and (drug related) fever</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary end-points include the establishment of an immune response against<br /><br>tumor asscoiated antigens and the model antigen KLH. Read-out parameters are<br /><br>the side effects, immune responses, anti-tumor response and survival of this<br /><br>DC-based immunotherapy* both in vivo and in vitro.</p><br>