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

Sponsor:	Transgene
Information provided by (Responsible Party):	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 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Interferon Interferon gamma-1b

U.S. FDA Resources

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 ]

Enrollment:	13
Study Start Date:	November 2006
Study Completion Date:	April 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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
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 Henri Mondor
Créteil, France, 94010
Hopital Lapeyronie
Montpellier, France, 34295
Hopital de l'Hotel-Dieu
Nantes, France, 44093
Poland
Katedra i Klinika Dermatologii Akademii Medycznej w Bydgoszczy
Bydgoszcz, Poland, 85-096
Klinika Dermatologii, Wenerologii i Alergologii
Gdańsk, Poland, 80-952
Serbia
Clinical Centre Serbia
Belgrade, Serbia, 11000
Switzerland
University Hospital of Zurich
Zurich, Switzerland, 8090

Sponsors and Collaborators

Transgene

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Transgene
ClinicalTrials.gov Identifier:	NCT00394693 History of Changes
Other Study ID Numbers:	TG1042.06
Study First Received:	October 31, 2006
Last Updated:	December 7, 2011
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

Additional relevant MeSH terms:

Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

Interferon-gamma
Interferon-gamma, Recombinant
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 22, 2012