NCT02926053

TIL Therapy for Metastatic Renal Cell Carcinoma

T Cell Therapy for Patients With Metastatic Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Inge Marie Svane · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Surgical removal of tumor tissue for T cell production	Surgical removal of \> 1 cm3 tumor tissue chosen with regards to high rate of success and to minimize the general risks involved in a surgical procedure.
DRUG	Cyclophosphamide	Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
DRUG	Fludarabine	Fludarabine 25 mg/m2 is administered on day -5 to day -1. Maximum dose of 50 mg per administration.
BIOLOGICAL	TIL infusion	The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
DRUG	Interleukin-2	Interleukin-2 is administered as high-dose bolus infusions (600.000 IU/kg) over a 15 minute period every 8 hours and continuing for up to 5 days (maximum of 15 doses).

Timeline

• Start date: 2016-12-01
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2016-10-06
• Last updated: 2024-11-22
• Results posted: 2024-11-22

Locations

1 site across 1 country: Denmark