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Blood, 15 September 2004, Vol. 104, No. 6, pp. 1631-1638.
Prepublished online as a Blood First Edition Paper on May 25, 2004July 8, 2004; DOI 10.1182/blood-2004-01-0360.
Previous Article | Next Article 
Submitted January 30, 2004
Accepted May 8, 2004
Adenovirus-mediated intralesional interferon- gene transfer induces tumor regressions in cutaneous lymphomas
Reinhard Dummer, Jessica C Hassel, Friederike Fellenberg, Stefan Eichmuller, Tanja Maier, Philippe Slos, Bruce Acres, Pascal Bleuzen, Vincent Bataille, Patrick Squiban, Guenter Burg, and Mirjana Urosevic*
Dermatology, University Hospital Zurich, Zurich, Switzerland
Skin Cancer Unit, German Cancer Research Center, Heidelberg, Germany
Transgene S.A., Strasbourg, France
* Corresponding author; email: Mirjana.Urosevic{at}usz.ch.
Primary cutaneous lymphomas have been successfully treated with interferons (IFNs), counterbalancing the Th2-skewing state. We undertook a phase I, open-label, dose-escalating trial of repeated, intratumoral administration of TG1042 in patients with advanced primary cutaneous T cell lymphomas (CTCL) and multilesional cutaneous B cell lymphomas (CBCL). TG1042 is a third generation, non-replicating human adenovirus vector containing human IFN- cDNA insert. Nine patients (7 CTCL, 2 CBCL) were enrolled at the following TG1042 doses: 3x109, 3x1010, and 3x1011 total particles. Local clinical response was observed in 5/9 treated patients [3 patients with complete (CR) and 2 patients with partial response (PR)]. Out of these, 3 patients showed systemic CR, with the clearance of other non-injected skin lesions. Clinical response lasted for a median of 3 months (range 1-6 mo). Adverse events were mostly of grade 1 and 2. 7/9 treated patients had detectable TG1042-derived IFN- message in injected lesions after the first treatment cycle. TG1042-IFN- message was also detectable after several treatment cycles. We demonstrate the induction of humoral immune response to lymphoma tumor-antigen se70-2 posttreatment. Our study shows that intralesional injections of TG1042 are both safe and well tolerated.

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