Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
T Cell Therapy for Patients With Metastatic Renal Cell Carcinoma
Adoptive T cell therapy (ACT) with tumor infiltrating lymphocytes (TIL) has achieved
impressive clinical results with durable complete responses in patients with metastatic
melanoma. The TILs are isolated from patients own tumor tissue followed by in vitro expansion
and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of
preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion
Interleukin-2 is administered to support T cell activation and proliferation in vivo.
Recent studies suggest, that TIL therapy works in other cancers than Metastatic Melanoma,
including Renal Cell Carcinoma. In this study TIL therapy is administered to patients with
metastatic Renal Cell Carcinoma.
Adoptive T cell therapy (ACT) with tumor infiltrating lymphocytes (TIL) has achieved
impressive clinical results with durable complete responses in patients with metastatic
melanoma. The TILs are isolated from patients own tumor tissue followed by in vitro expansion
and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of
preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion
Interleukin-2 is administered to support T cell activation and proliferation in vivo.
Objectives:
To evaluate safety and feasibility when treating patients with metastatic renal cell
carcinoma with ACT with TILs.
To evaluate treatment related immune responses . To evaluate clinical efficacy.
Design:
Patients will be screened with a physical exam, medical history, blood samples, pulmonary
function test, Cr-EDTA clearance, MUGA scan and ECG.
Patients will undergo surgery to harvest tumor material for TIL production.
Patients is admitted day -8 in order to undergo lymphodepleting chemotherapy with
cyclophosphamide and fludara starting day -7.
On day 0 patients receive TIL infusion and shortly after starts IL-2 administration with
high-dose bolus IL-2 every eight hour for up to 5 days (maximum of 15 doses).
The patients will followed until progression or up to 5 years.
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