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A Pilot Study of Combined Suicide/Cytokine Gene Therapy in Two Patients with End-Stage Anaplastic Thyroid Carcinoma

Department of Histology, Microbiology, and Medical Biotechnologies, University of Padova (L.B., M.P., E.F., G.P.), I-35121 Padova, Italy; and Department of Internal Medicine, University of Ancona (A.T., M.Br., M.Bo.), I-60100 Torrette, Ancona, Italy

Address all correspondence and requests for reprints to: Dr. Luisa Barzon, Department of Histology, Microbiology, and Medical Biotechnologies, University of Padova, Via Gabelli 63, I-35121 Padova, Italy. E-mail: luisa.barzon{at}unipd.it.

This study represents the first report of gene therapy for anaplastic thyroid carcinoma, one of the most aggressive solid tumors in humans. Two patients with end-stage anaplastic thyroid carcinoma were treated by direct intratumor injection of retroviral vector producer cells followed by ganciclovir. The retroviral vector carried the human IL-2 gene and the suicide gene thymidine kinase of herpes simplex virus type 1. Treatment was safe and associated with only mild adverse events. Transduction of tumor cells and production of T helper type 1 cytokines was demonstrated in tumor biopsies. Gene therapy led also to a marked increase in T helper type 1 cytokine expression in peripheral blood mononuclear cells. Radiological evaluation of injected tumor masses demonstrated local tumor necrosis.

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