Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-cell Lymphoma
Lead Sponsor:
Transgene
Conditions:
Lymphoma, B-Cell
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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-tumora...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00394693
Start Date
November 1 2006
End Date
April 1 2010
Last Update
July 16 2014
Active Locations (6)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305-5334
2
Northwestern University Medical School
Chicago, Illinois, United States, 60611
3
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
4
Hopital Lapeyronie
Montpellier, France, 34295