Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-cell Lymphoma
- Conditions
- Lymphoma, B-Cell
- Registration Number
- NCT00394693
- Lead Sponsor
- Transgene
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Regression and disappearance of lesions end of cycle Safety visit
- Secondary Outcome Measures
Name Time Method Quality of Life visit
Trial Locations
- Locations (6)
Stanford University School of Medicine
🇺🇸Stanford, California, United States
Northwestern University Medical School
🇺🇸Chicago, Illinois, United States
Hopital Lapeyronie
🇫🇷Montpellier, France
M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Hopital de l'Hotel-Dieu
🇫🇷Nantes, France
University Hospital of Zurich
🇨ðŸ‡Zurich, Switzerland