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Sponsored by: |
Transgene |
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 |
Lymphoma, B-Cell |
Genetic: Adenovirus Interferon gamma |
Phase II |
MedlinePlus related topics: | Cancer Lymphoma |
ChemIDplus related topics: | Interferon alfa-2b Interferons Interferon gamma-1b |
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 | Recruiting | ||||
Stanford, California, United States, 94305-5334 | |||||
Contact: Youn H. KIM, M.D. 650-723-7893 younkim@stanford.edu | |||||
Principal Investigator: Youn H KIM, M.D. | |||||
United States, Illinois | |||||
Northwestern University Medical School | Recruiting | ||||
Chicago, Illinois, United States, 60611 | |||||
Contact: Joan GUITART, M.D. 312-695-4174 j-guitart@northwestern.edu | |||||
Principal Investigator: Joan GUITART, M.D. | |||||
United States, Texas | |||||
M.D. Anderson Cancer Center | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Contact: Madeleine DUVIC, M.D. 713-745-1113 mduvic@mdanderson.org | |||||
Principal Investigator: Madeleine DUVIC, M.D. | |||||
France | |||||
Hopital de l'Hotel-Dieu | Recruiting | ||||
Nantes, France, 44093 | |||||
Contact: Brigitte DRENO, M.D. +33-240-083-116 brigitte.dreno@wanadoo.fr | |||||
Principal Investigator: Brigitte DRENO, M.D. | |||||
Hopital Lapeyronie | Recruiting | ||||
Montpellier, France, 34295 | |||||
Contact: Jean François ROSSI, M.D. +33-467-338-079 jf-rossi@chu-montpellier.fr | |||||
Principal Investigator: Jean François ROSSI, M.D. | |||||
Hopital Henri Mondor | Recruiting | ||||
Créteil, France, 94010 | |||||
Contact: Martine BAGOT, M.D. +33-149-812-501 martine.bagot@hmn.aphp.fr | |||||
Principal Investigator: Martine BAGOT, M.D. | |||||
Poland | |||||
Klinika Dermatologii, Wenerologii i Alergologii | Recruiting | ||||
Gdańsk, Poland, 80-952 | |||||
Contact: Malgorzata Sokolowska-Wojdylo, MD +48 (58) 349 25 80 mwojd@amg.gda.pl | |||||
Principal Investigator: Jadwiga ROSZKIEWICZ, Pr | |||||
Katedra i Klinika Dermatologii Akademii Medycznej w Bydgoszczy | Recruiting | ||||
Bydgoszcz, Poland, 85-096 | |||||
Contact: Aleksandra Grzanka, MD +48 (52) 585-45-68 aleksandrag@op.pl | |||||
Principal Investigator: Waldemar PLACEK, Pr | |||||
Serbia and Montenegro | |||||
Clinical Centre Serbia | Recruiting | ||||
Belgrade, Serbia and Montenegro, 11000 | |||||
Contact: Biljana MIHALJEVIC, Pr +381 65 2457597 bimih@eunet.yu | |||||
Principal Investigator: Biljana MIHALJEVIC, Pr | |||||
Switzerland | |||||
University Hospital of Zurich | Recruiting | ||||
Zurich, Switzerland, 8090 | |||||
Contact: Reinhard G. DUMMER, M.D. +41-44-255-2550 reinhard.dummer@usz.ch | |||||
Principal Investigator: Reinhard G. DUMMER, D.M. |
Transgene |
Related Info 
  |
Responsible Party: | Transgene ( M. Lusky ) |
Study ID Numbers: | TG1042.06 |
First Received: | October 31, 2006 |
Last Updated: | March 27, 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 |
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