TIL Therapy for Metastatic Renal Cell Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Renal Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
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 wee...
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.
Tracking Information
- NCT #
- NCT02926053
- Collaborators
- Not Provided
- Investigators
- Study Director: Inge Marie Svane, Prof., MD Center for Cancer Immune Therapy, Dept. of Oncology/Hematology, Copenhagen University Hospital Herlev, Herlev Ringvej 75, DK-2730 Principal Investigator: Magnus Pedersen, MD Center for Cancer Immune Therapy, Dept. of Oncology/Hematology, Copenhagen University Hospital Herlev, Herlev Ringvej 75, DK-2730