title: Phase II clinical trial of intratumoral application of TG1042 (adenovirus-interferon-gamma) in patients with advanced cutaneous T-cell lymphomas and multilesional cutaneous B-cell lymphomas.
abstract: Cutaneous lymphomas (CLs) are a heterogeneous group of lymphoproliferative disorders that are manageable by immunotherapy. Twenty-one patients were enrolled in a prospective open-label, dose-escalation multicenter study evaluating the effects of repeated TG1042 [adenovirus-interferon (IFN)-gamma] intralesional injections in patients with primary CLs, of which 18 were of T-cell and 3 of B-cell type. Repeated intralesional therapy using TG1042 consistently results in local tumor regressions in about half of treated patients and one-third of patients also in regressions in noninjected distant lesions, likely reflecting the systemic immune activation after intralesional therapy. Treatment was well tolerated with few adverse events including injection site reactions, chills, lymphopenia, and fever. Immune monitoring in the peripheral blood demonstrated systemic immune activation and the induction of antibodies against tumor antigens in some patients without clear association with clinical responses. CLs, in particular B-cell lymphomas with high objective response rates, seem to be excellent targets for this type of immunotherapy.
authors.affiliation: Department of Dermatology, University Hospital, Zurich, Switzerland. reinhard.dummer@usz.ch
authors.forename: Reinhard
authors.initials: R
authors.lastname: Dummer
authors.forename: Stefan
authors.initials: S
authors.lastname: Eichmüller
authors.forename: Sylke
authors.initials: S
authors.lastname: Gellrich
authors.forename: Chalid
authors.initials: C
authors.lastname: Assaf
authors.forename: Brigitte
authors.initials: B
authors.lastname: Dreno
authors.forename: Meinhard
authors.initials: M
authors.lastname: Schiller
authors.forename: Olivier
authors.initials: O
authors.lastname: Dereure
authors.forename: Marion
authors.initials: M
authors.lastname: Baudard
authors.forename: Martine
authors.initials: M
authors.lastname: Bagot
authors.forename: Amir
authors.initials: A
authors.lastname: Khammari
authors.forename: Pascal
authors.initials: P
authors.lastname: Bleuzen
authors.forename: Vincent
authors.initials: V
authors.lastname: Bataille
authors.forename: Anna
authors.initials: A
authors.lastname: Derbij
authors.forename: Nicole
authors.initials: N
authors.lastname: Wiedemann
authors.forename: Tim
authors.initials: T
authors.lastname: Waterboer
authors.forename: Monika
authors.initials: M
authors.lastname: Lusky
authors.forename: Bruce
authors.initials: B
authors.lastname: Acres
authors.forename: Mirjana
authors.initials: M
authors.lastname: Urosevic-Maiwald
mesh_terms: D000256:Adenoviridae / Q000235:genetics*; D006801:Humans; D015552:Injections, Intralesional; D007371:Interferon-gamma / Q000008:administration & dosage / Q000235:genetics / Q000627:therapeutic use*; D016393:Lymphoma, B-Cell / Q000188:drug therapy*; D016399:Lymphoma, T-Cell / Q000188:drug therapy*; D012878:Skin Neoplasms / Q000628:therapy*
chemical_list: D007371:Interferon-gamma