An autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Urothelial Carcinoma Patients.
This is a phase II single-center study of Tumor Infiltrating Lymphocytes (TIL) in urothelial carcinoma patients who failed at least one line of platinum based chemotherapy and one line of immunotherapy of targeted therapy. Patients will undergo a baseline evaluation including imaging, blood and urine samples, EVG and physical examination to confirm suitability for the study. Eligible patients will undergo surgery to collect a tumor sample for TIL culturing. Patients will receive an autologus TIL infusion once the cells have been properly cultured. Following the infusion, patients will receive a high dose of IL-2. Following the intervention, patients will be monitored to evaluate study endpoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patient with metastatic urothelial carcinoma will undergo a autologous lymphocyte transplantation. Patient will undergo surgery to remove either the primary tumor or a tumor metastasis. The cells collected in this surgey will be cultured and reintroduced to the patient. Following the cell infusion, patient will receive a high-dose bolus of IL-2.
high-dose (720,000 IU/kg) IL-2 will be administered every 8 hours, to tolerance. A maximum of 10 doses will be administered
Sheba Medical Center
Ramat Gan, Israel
RECRUITINGEfficacy endpoint Objective Tumor response according to RECICT 1.1
The primary efficacy endpoint is defined as at least a 20% clinical benefit expressed as the sum of CR+PR+SD (each of these parameters defined as persisting for at least for 12 weeks).
Time frame: 3 Years
Safety endpoint Assess Adverse Events using CTCAE V4.03 during treatment and FU
The primary safety endpoint of the study is to evaluate the overall toxicity profile of the ACT procedure, with an emphasis on the side effects of the reduced intensity, non-myeloablative, lymphodepleting induction regimen.
Time frame: 3 Years
Overall Survival
Overall Survival (OS) according to RECICT 1.1
Time frame: 3 Years
Progression-Free Survival
Progression-Free Survival (PFS) according to RECICT 1.1
Time frame: 3 Years
Quality of Life (QoL) Assessment
Assessment of QoL using disease specific modules of the EORTC QLQ-C30 (version 3.0)
Time frame: 3 Years
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