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Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-Cell Lymphoma

This study is currently recruiting participants.
Verified by Transgene, March 2008

Sponsored by: 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

MedlinePlus related topics:   Cancer    Lymphoma   

ChemIDplus related topics:   Interferon alfa-2b    Interferons    Interferon gamma-1b   

U.S. FDA Resources

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.

Further study details as provided by Transgene:

Primary Outcome Measures:
  • Regression and disappearance of lesions [ Time Frame: end of cycle ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: visit ] [ Designated as safety issue: No ]

Estimated Enrollment:   41
Study Start Date:   November 2006
Estimated Primary Completion Date:   March 2009 (Final data collection date for primary outcome measure)

Intervention Details:
    Genetic: Adenovirus Interferon gamma
    intra-tumoral injections, 1 dose per lesion, up to 6 simultaneous lesions.
  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 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 Criteria:

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394693

Locations
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.            

Sponsors and Collaborators
Transgene
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by Transgene:
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

Study placed in the following topic categories:
Immunoproliferative Disorders
Interferon Type II
Adenoviridae Infections
Interferons
Lymphoma, B-Cell, Marginal Zone
Lymphoma, B-Cell
Lymphatic Diseases
B-cell lymphomas
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Interferon Alfa-2b
Interferon-gamma, Recombinant

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008




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