patients affected by advanced or metastatic small cell lung carcinoma SCLC previously treated with no more than one therapeutic regimen MedDRA version: 9.1 Level: LLT Classification code 10059514 Term: Small cell lung cancer metastatic
Conditions
Sponsors
MOLMED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients 18 years affected by SCLC previously treated with no more than one therapeutic regimen Measurable disease according to RECIST criteria ECOG Performance status 0 2 Adequate baseline bone marrow, hepatic and renal function, defined as follows Neutrophils 1.5 x 109/L and platelets 100 x 109/L;Bilirubin 1.5 x ULN;AST and/or ALT 2.5 x ULN in absence of liver metastasis;AST and/or ALT 5 x ULN in presence of liver metastasis;Serum creatinine 1.5 x ULN Absence of any conditions in which hypervolaemia and its consequences e.g. increased stroke volume, elevated blood pressure or haemodilution could represent a risk for the patient reference appendix Technical data sheet human albumin Normal cardiac function and absence of uncontrolled hypertension written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Concurrent anticancer therapy Patients may not receive any other investigational agents while on study Clinical signs of CNS involvement Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Antitumour activity defined as progression free survival PFS ;Secondary Objective: Tumor Growth Control Rate TGCR Evaluation of Circulating Tumor Cells CTCs and Circulating Endothelial Cells CECs Experimental Imaging Study DCE-MRI Evaluation of adaptative immune response Safety;Primary end point(s): Antitumour activity defined as progression free survival PFS | — |
Countries
Italy
Outcome results
None listed