Tumour-Infiltrating Lymphocytes and Low-Dose Interleukin-2 Therapy Following Cyclophosphamide and Fludarabine in Patients With Pleural Mesothelioma

Official Title

Phase I/II Study Evaluating the Infusion of Tumour-Infiltrating Lymphocytes (TILs) and Low-Dose Interleukin-2 (IL-2) Therapy Following a Preparative Regimen of Non-myeloablative Lymphodepletion Using Cyclophosphamide and Fludarabine in Patients With Malignant Pleural Mesothelioma

Summary:

This is a phase I and II clinical study for patients with malignant pleural mesothelioma (a type of cancer affecting the lining of the lung). Patients will receive an infusion (given by vein) of autologous tumour infiltrating lymphocytes (TILs). TILs are a type of white blood cells that recognizes tumour cells and enter them which causes the tumour cells to break down. Prior to the cell infusion, patients will receive a two drugs cyclophosphamide and fludarabine to prepare the body to receive the TILs. After cell infusion, patients will receive low-dose interleukin-2 therapy. This study will see how safe and useful this regimen is in treating malignant pleural mesothelioma.

Trial Description

Primary Outcome:

• Total number of adverse events for each event reported and the severity and attribution to study therapy of each event

• Percentage of patients with a clinical response to the study treatment

View this trial on ClinicalTrials.gov