Spots Global Cancer Trial Database for Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors

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Trial Identification

Brief Title: Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors

Official Title: Phase Ib Study To Assess The Feasibility And Safety Of Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes In Advanced Solid Tumors

Study ID: NCT03992326

Conditions

Solid Tumor, Adult

Interventions

Study Description

Brief Summary: Single center, single arm phase Ib trial to test the feasibility and safety of Tumor- Infiltrating Lymphocyte-Adoptive Cell Therapy (TIL-ACT) combined with low-dose irradiation in patients with advanced or metastatic solid tumors. The trial is based on lymphodepleting chemotherapy followed by low dose irradiation (LDI), and then ACT utilizing ex vivo expanded TILs in combination with high dose IL-2 (optional, depending on patient's tolerance). LDI will be administered once to metastatic lesions using tomotherapy.

Detailed Description: The objective of the trial is to define the feasibility and safety of TIL-ACT in combination with low-dose irradiation (LDI) in patients with advanced or metastatic solid tumors. Study treatment will begin with intravenous (IV) non-myeloablative (NMA) lymphodepleting chemotherapy composed by fludarabine and cyclophosphamide. Both treatments will be started on the same day. Fludarabine will be administered for five days, and cyclophosphamide for two days. Low-dose irradiation (LDI) will be then administered once, to up to 20 measurable tumor lesions using tomotherapy. TIL infusion will be performed intravenously followed by high dose IL-2 administration every eight hours, for a maximum of eight doses. Supportive care will be given as needed during the whole treatment period. Patients achieving a stable disease, partial response or complete response after TIL-ACT treatment will then enter a follow-up period for 5 years.