asbestos cancer malignant pleural mesothelioma
Conditions
Interventions
Subjects in Arm A receive maintenance therapy.
After randomization subjects in Arm A will undergo leukapheresis to obtain
monocytes from which dendritic cells will be generated. These dendritic cells
Sponsors
Amphera B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Signed informed consent within 8 weeks of their last chemo and the date of the informed consent must be such that it is possible to schedule the first study treatment 9 to 13 weeks after their last chemo therapy. - Histologically confirmed diagnosis of pleural malignant mesothelioma, non-progressive after 4 to 6 cycles with first line chemotherapy with antifolate/cisplatin (as determined by CT scanning) - Measurable disease on CT scanning, by modified RECIST criteria or RECIST 1.1. In absence of measurable disease a CT scan is needed to evaluate the disease. - At least 18 years old - WHO-ECOG performance status of 0 or 1
Exclusion criteria
Exclusion criteria: - any concurrent medical, psychological or psychiatric disease or condition that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study - serious intercurrent chronic or acute illness such as cardiac or hepatic disease considered by the investigator to constitute an unwarranted high risk for investigational dendritic cell treatment - known active acute or chronic infection, including human immunodeficiency virus (HIV) and hepatitis B or C -history of autoimmune disease -subjects with an organ allograft
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the overall survival. Overall survival will be determined as the time from randomization until death. For subjects who are alive at the end of the study or lost to follow-up, OS will be censored on the last date when subjects are known to be alive. | — |
Secondary
| Measure | Time frame |
|---|---|
| • the estimated survival rate at 12 and 18 months after randomization will be determined with the Kaplan Meier analysis. • Progression-free survival (PFS), including symptomatic progression-free survival. The time of the first CT scan showing progression will define the end of the PFS. • Overall response rate and duration of response. Overall response rate is defined as the proportion of subjects with confirmed CR or PR on CT scans, if possible measured following modified RECIST criteria. • Change in quality of life: the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and its lung cancer (LC)-specific module EORTC QLQ - LC13 will be used to evaluate quality of life. Measures of QoL will be compared to baseline and changes over time and compared to each other. • safety and tolerability of MesoPher: adverse events and serious adverse events, including local and systemic injection site reactions, laboratory assessments, electrocardiogram, vital signs, physical examination, and ECOG performance status. | — |
Countries
Netherlands
Outcome results
None listed