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Sponsored by: |
Transgene |
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Information provided by: | Transgene |
ClinicalTrials.gov Identifier: | NCT00394693 |
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.
Condition | Intervention | Phase |
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Lymphoma, B-Cell |
Genetic: Adenovirus Interferon gamma |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Clinical Trial of Intra-Lesional Administration of TG1042 (Adenovirus-Interferon-Gamma) in Patients With Relapsing Primary Cutaneous B-Cell Lymphomas. |
Estimated Enrollment: | 41 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Primary CBCL including (according to WHO/EORTC classification 2005) :
Primary cutaneous diffuse large B-cell other than leg type
Exclusion Criteria:
Patients will be excluded from the study for any of the following reasons:
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305-5334 | |
United States, Illinois | |
Northwestern University Medical School | |
Chicago, Illinois, United States, 60611 | |
United States, Texas | |
M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Croatia | |
Institute of Haematology | |
ZAGREB, Croatia, 10000 | |
France | |
Hopital de l'Hotel-Dieu | |
Nantes, France, 44093 | |
Hopital Lapeyronie | |
Montpellier, France, 34295 | |
Hopital Henri Mondor | |
Créteil, France, 94010 | |
Poland | |
Klinika Dermatologii, Wenerologii i Alergologii | |
Gdańsk, Poland, 80-952 | |
Katedra i Klinika Dermatologii Akademii Medycznej w Bydgoszczy | |
Bydgoszcz, Poland, 85-096 | |
Serbia | |
Clinical Centre Serbia | |
Belgrade, Serbia, 11000 | |
Switzerland | |
University Hospital of Zurich | |
Zurich, Switzerland, 8090 |
Responsible Party: | Transgene ( M. Lusky ) |
Study ID Numbers: | TG1042.06 |
Study First Received: | October 31, 2006 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00394693 |
Health Authority: | United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Switzerland: Swissmedic; Poland: Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices |
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 |
Lymphoma, B-Cell Lymphatic Diseases Immunoproliferative Disorders Interferon Type II B-cell lymphomas Adenoviridae Infections |
Interferons Lymphoma, B-Cell, Marginal Zone Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Interferon-gamma, Recombinant |
Anti-Infective Agents Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Antiviral Agents Pharmacologic Actions |