Phase I/II study of adenovirus-interferon-γ (TG1042) in primary cutaneous lymphomas (CL)

3039 Background: CL has been successfully treated with interferons (IFNs), which can offset the Th2 dominance associated with CL. Intratumoral (IT) injection of TG1042 (a non-replicating recombinant adenovirus with a human IFN-g cDNA insert) allows high local levels of IFN-g without severe toxicity induced by systemic delivery. Methods: We undertook a phase I/II, open-label, trial of repeated, IT injection of TG1042 in patients with advanced primary T cell (CTCL) and multilesional B cell (CBCL) cutaneous lymphomas. The designated lesions were injected on days 1, 8, and 15 with no injection in the fourth week (1 cycle) and thereafter up to 4 cycles. Immunohistochemistry and qPCR were performed on injected lesions biopsied at baseline and after each cycles. In the phase I, 9 patients were enrolled in 3 successive cohorts at the doses of 3x10E9 total particles (tp), 3x10E10 and 3x10E11 tp. In the phase II, 7 out of 27 additional planned patients have been treated at 3x10E11 tp. Results: To date 12 CTCL and 4...