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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394693
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):

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-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 or disease Intervention/treatment Phase
Lymphoma, B-Cell Genetic: Adenovirus Interferon gamma Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Intra-lesional Administration of TG1042 (Adenovirus-Interferon-gamma) in Patients With Relapsing Primary Cutaneous B-Cell Lymphomas.
Study Start Date : November 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2010

Intervention Details:
  • Genetic: Adenovirus Interferon gamma
    intra-tumoral injections, 1 dose per lesion, up to 6 simultaneous lesions.

Primary Outcome Measures :
  1. Regression and disappearance of lesions [ Time Frame: end of cycle ]
  2. Safety [ Time Frame: visit ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: visit ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00394693

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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
Hopital Lapeyronie
Montpellier, France, 34295
Hopital de l'Hotel-Dieu
Nantes, France, 44093
University Hospital of Zurich
Zurich, Switzerland, 8090
Sponsors and Collaborators
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Transgene Identifier: NCT00394693    
Other Study ID Numbers: TG1042.06
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
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
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents