study to evaluate the safety and efficacy of adeno-ifn gamma in cutaneous b-cell lymphoma

Conditions: Lymphoma, B-Cell

Summary: the primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of tg1042 in patients with relapsing cbcl. patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (tg1042), in an attempt to enhance immune responses with anti-tumor activity. this local administration induces tumour cell killing at the injected tumour sites.


Eligibility criteria:
inclusion criteria: * patients must satisfy all the following criteria for entry into the protocol: primary cbcl including (according to who/eortc classification 2005) : * primary cutaneous marginal zone b-cell lymphoma * primary cutaneous follicle center b-cell lymphoma * primary cutaneous diffuse large b-cell other than leg type * histologically consistent with primary cbcl. * relapse or active disease after radiotherapy or other adequate therapy if radiotherapy was contra-indicated (chemotherapy, surgical excision, interferonα, rituximab). * performance status of 0, 1 on the eastern cooperative oncology group (ecog) scale (see appendix e). * minimum life expectancy \> 3 months. * adequate blood count: hemoglobin \>= 10.0 g/dl; white blood count (wbc) \>= 3.0 x 109/l; and platelet count \>= 75 x 109/l. * adequate hepatic function: bilirubin =\< 1.5 times the upper limit of normal and serum transaminase (sgot and sgpt)=\< 2.5 times the upper limit of normal. * adequate renal function: creatinine =\< 1.5 times the upper limit of normal. * written informed consent from patient. exclusion criteria: patients will be excluded from the study for any of the following reasons: * primary cutaneous diffuse large b-cell lymphoma, leg type. * primary cutaneous intravascular large b-cell lymphoma. * extracutaneous involvement (sign of b-cell lymphoma on thoraco-abdominal ct scan and/or pet scan and/or on bone marrow biopsy). * no histologic documentation of cbcl. * history of known human immuno-deficiency virus, human hepatitis b or c positive serology or other active systemic infections. * serious uncontrolled, concomitant medical disorders. * concomitant therapy for cbcl: surgical resection, radiotherapy, corticosteroid, chemotherapy, rituximab...(not limited listing) * major surgery in previous 4 weeks preceding the 1st injection. * pregnancy at study entry or who become pregnant during the study or women who are breast feeding. * males and females of reproductive potential who refuse to use adequate protection against pregnancy (intra-uterine device, hormonal contraception or diaphragm/condom and spermicide) during the conduct of the study and for three months after the last injection. * participation in another experimental protocol during the study period and within 4 weeks prior to the first injection. * patient previously included in this study. * non compliance with the study.

Keywords: primary cbcl including (who/eortc classification 2005) primary cutaneous marginal zone b-cell lymphoma primary cutaneous follicle center b-cell lymphoma primary cutaneous diffuse large b-cell other than leg type histologically consistent with primary cbcl relapse or active disease