Phase II Clinical Trial of Intra-lesional Administration of TG1042 (Adenovirus-Interferon-gamma) in Patients With Relapsing Primary Cutaneous B-Cell Lymphomas.
- 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,
- 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.
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
- 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
- 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.