Malignant pleural mesothelioma or metastatic NSCLC Maligne longvlieskanker of uitgezaaide longkanker (NSCLC)
Conditions
Interventions
Pleural fluid that is drawn for symptom relief, will be used to isolate tumor cells for short-term culture. A small scale drug screen will be performed within 3 weeks after isolation of tumor cells. I
Sponsors
Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Inclusion criteria
Inclusion criteria: • Patients with histologically or cytologically proven malignant mesothelioma or non-small cell lung cancer that have a pleural effusion. • Age >18 years. • At the time of pleural fluid drainage, patients must have completed: For MPM: at least first-line chemotherapy with a platinum (cisplatin or carboplatin) and pemetrexed combination. For NSCLC: at least first and second line therapy according to the local guidelines. • At the start of study treatment, patients must have documented evidence of progressive disease. • Measurable or evaluable disease. • Ability to understand the study and give signed informed consent prior to beginning of protocol specific procedures. • WHO performance status ≤ 2 • Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry: o Hematology: Neutrophil count ≥ 1.5 x 109/l, Platelets ≥ 100 x 109/l, Hemoglobin ≥ 5.9 mmol/l. o Hepatic function as defined by serum bilirubin ≤ 1.25 times the upper limit of normal (ULN), ALAT and ASAT ≤ 2.5 times the ULN, except for liver metastases then ALAT and ASAT < 5 times the ULN. o Renal function as defined by serum creatinine ≤ 1.25 times ULN or creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula).
Exclusion criteria
Exclusion criteria: • Active uncontrolled infection, severe cardiac dysfunction or non-correctable bleeding tendency. • Any identification of a driver mutation for which a registered treatment is available • Presence of symptomatic CNS metastases. • Radiotherapy within 2 weeks prior to start of study treatment. • Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition. • Concomitant administration of any other experimental drugs under investigation. • Any non-resolved grade 3 or higher toxicity. • For neurotoxicity any non-resolved grade 2 or higher toxicity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is accuracy of the drug profiling method, defined by the number of truly predicted responses, as a percentage of the total number of patients in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include objective response rates (ORR), progression free survival (PFS), overall survival (OS), pulmonary function and frequency and severity of adverse events. Exploratory endpoints to identify potential biomarkers include genomic profiling and assessment of the accuracy of response evaluation by breath prints of Volatile Organic Compounds by SpiroNose. | — |
Contacts
Public ContactP. Baas
The Netherlands Cancer Insitute, Department of Pulmonology Plesmanlaan 121
Outcome results
None listed