At a glance
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T Cell Therapy for Patients With Metastatic Renal Cell Carcinoma
In Brief
A Phase 1 clinical trial evaluating Surgical removal of tumor tissue for T cell production, Cyclophosphamide, and 3 other interventions for Metastatic Renal Cell Carcinoma. Completed, enrolled 5 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine 25 mg/m2 is administered on day -5 to day -1. Maximum dose of 50 mg per administration.
The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
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).