TG1042 (Adenovirus-interferon-γ) in primary cutaneous B-cell lymphomas: a phase II clinical trial.

Abstract

RATIONAL:

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).

METHOD:

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.

TRIAL REGISTRATION:

www.clinicaltrials.govNCT00394693.

• Authors: Brigitte Dreno, Mirjana Urosevic-Maiwald, Youn Kim, Joan Guitart, Madeleine Duvic, Olivier Dereure, Amir Khammari, Anne-Chantal Knol, Anna Derbij, Monika Lusky, Isabelle Didillon, Anne-Marie Santoni, Bruce Acres, Vincent Bataille, Marie-Pierre Chenard, Pascal Bleuzen, Jean-Marc Limacher, Reinhard Dummer
• Journal: PloS one (PLoS One) Vol. 9 Issue 2 Pg. e83670 ( 2014) ISSN: 1932-6203 [Electronic] United States
• PMID: 24586226 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Interferon-gamma

Topics

• Adenoviridae (metabolism)
• Adult
• Aged
• Aged, 80 and over
• Disease Progression
• Female
• Humans
• Injections, Intralesional (methods)
• Interferon-gamma (administration & dosage)
• Lymphoma, T-Cell, Cutaneous (drug therapy, pathology)
• Male
• Middle Aged
• Skin Neoplasms (drug therapy, pathology)