title: TG1042 (Adenovirus-interferon-γ) in primary cutaneous B-cell lymphomas: a phase II clinical trial.
abstract: BACKGROUND
  While a variety of registered therapies exist for Cutaneous T Cell Lymphoma, no such therapy is available for Cutaneous B Cell Therapy. In this context we performed a phase II, open label, multicenter, non-comparative study to evaluate the efficacy and safety of repeated intra-lesional administrations of TG1042 (adenovirus-interferon-γ) in patients with relapsing primary cutaneous B-cell lymphomas (CBCL).
  
  
  METHODS
  Thirteen patients have been enrolled and received intralesional injections of TG1042 containing 5×10(10) viral particles into up to six lesions simultaneously. Injections were performed on days 1, 8 and 15 of each of four consecutive 28 day cycles.
  
  
  RESULTS
  Eleven (85%) out of 13 enrolled patients showed an objective response after injections of TG1042. Seven patients (54%) exhibited complete and four (31%) displayed partial response. The median time to disease progression in the study population was 23.5 months (range 6.25 to 26+). Most commonly observed adverse events were minor to moderate flu-like symptoms, fatigue and injection site reactions.
  
  
  CONCLUSIONS
  Our study showed that treatment with TG1042 was associated with a clinical benefit in the majority of the patients with relapsing CBCL, including tumor regression, a clinically meaningful duration of response and a good treatment tolerance.
  
  
  BACKGROUND
  www.clinicaltrials.govNCT00394693.
authors.affiliation: Department of Skin Cancer, University Hospital, Nantes, France.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Dreno
authors.affiliation: Department of Dermatology, University Hospital, Zurich, Switzerland.
authors.forename: Mirjana
authors.initials: M
authors.lastname: Urosevic-Maiwald
authors.affiliation: Stanford University School of Medicine, Stanford, California, United States of America.
authors.forename: Youn
authors.initials: Y
authors.lastname: Kim
authors.affiliation: Northwestern University Medical School, Chicago, Illinois, United States of America.
authors.forename: Joan
authors.initials: J
authors.lastname: Guitart
authors.affiliation: University of Texas, M.D. Anderson Cancer Center, Houston, Texas, United States of America.
authors.forename: Madeleine
authors.initials: M
authors.lastname: Duvic
authors.affiliation: Department of Dermatology, Saint Eloi Hospital, Montpellier, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Dereure
authors.affiliation: Department of Skin Cancer, University Hospital, Nantes, France.
authors.forename: Amir
authors.initials: A
authors.lastname: Khammari
authors.affiliation: Department of Skin Cancer, University Hospital, Nantes, France.
authors.forename: Anne-Chantal
authors.initials: AC
authors.lastname: Knol
authors.affiliation: Transgene, Illkirch (Strasbourg), France.
authors.forename: Anna
authors.initials: A
authors.lastname: Derbij
authors.affiliation: Transgene, Illkirch (Strasbourg), France.
authors.forename: Monika
authors.initials: M
authors.lastname: Lusky
authors.affiliation: Transgene, Illkirch (Strasbourg), France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Didillon
authors.affiliation: Transgene, Illkirch (Strasbourg), France.
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Santoni
authors.affiliation: Transgene, Illkirch (Strasbourg), France.
authors.forename: Bruce
authors.initials: B
authors.lastname: Acres
authors.affiliation: Transgene, Illkirch (Strasbourg), France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Bataille
authors.affiliation: Department of Pathology, University Hospital, Strasbourg, France.
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Chenard
authors.affiliation: Transgene, Illkirch (Strasbourg), France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Bleuzen
authors.affiliation: Transgene, Illkirch (Strasbourg), France.
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Limacher
authors.affiliation: Department of Dermatology, University Hospital, Zurich, Switzerland.
authors.forename: Reinhard
authors.initials: R
authors.lastname: Dummer
mesh_terms: D000256:Adenoviridae / Q000378:metabolism*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018450:Disease Progression; D005260:Female; D006801:Humans; D015552:Injections, Intralesional / Q000379:methods; D007371:Interferon-gamma / Q000008:administration & dosage*; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D007371:Interferon-gamma