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| Sponsor: | Transgene |
|---|---|
| Information provided by: | Transgene |
| ClinicalTrials.gov Identifier: | NCT00394693 |
Purpose
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 |
|---|---|---|
|
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) |
Eligibility| 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:
Contacts and Locations| 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 | |
More Information
| 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 History of Changes |
| 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 |
|
Anti-Infective Agents Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Interferon Type II Antineoplastic Agents Interferons Antiviral Agents Pharmacologic Actions |
Lymphoma, B-Cell Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Interferon-gamma, Recombinant |