Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-cell Lymphoma

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.