Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-cell Lymphoma
Phase II Clinical Trial of Intra-lesional Administration of TG1042 (Adenovirus-Interferon-gamma) in Patients With Relapsing Primary Cutaneous B-Cell Lymphomas.
1 other identifier
interventional
13
3 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2006
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2006
CompletedFirst Posted
Study publicly available on registry
November 1, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJuly 16, 2014
July 1, 2014
3.2 years
October 31, 2006
July 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Regression and disappearance of lesions
end of cycle
Safety
visit
Secondary Outcomes (1)
Quality of Life
visit
Interventions
intra-tumoral injections, 1 dose per lesion, up to 6 simultaneous lesions.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Transgenelead
Study Sites (6)
Stanford University School of Medicine
Stanford, California, 94305-5334, United States
Northwestern University Medical School
Chicago, Illinois, 60611, United States
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Hopital Lapeyronie
Montpellier, 34295, France
Hopital de l'Hotel-Dieu
Nantes, 44093, France
University Hospital of Zurich
Zurich, 8090, Switzerland
Related Publications (2)
Dreno B, Urosevic-Maiwald M, Kim Y, Guitart J, Duvic M, Dereure O, Khammari A, Knol AC, Derbij A, Lusky M, Didillon I, Santoni AM, Acres B, Bataille V, Chenard MP, Bleuzen P, Limacher JM, Dummer R. TG1042 (Adenovirus-interferon-gamma) in primary cutaneous B-cell lymphomas: a phase II clinical trial. PLoS One. 2014 Feb 24;9(2):e83670. doi: 10.1371/journal.pone.0083670. eCollection 2014.
PMID: 24586226DERIVEDAccart N, Urosevic-Maiwald M, Dummer R, Bataille V, Kehrer N, Niculescu C, Limacher JM, Chenard MP, Bonnefoy JY, Rooke R. Lymphocytic infiltration in the cutaneous lymphoma microenvironment after injection of TG1042. J Transl Med. 2013 Sep 25;11:226. doi: 10.1186/1479-5876-11-226.
PMID: 24063735DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2006
First Posted
November 1, 2006
Study Start
November 1, 2006
Primary Completion
January 1, 2010
Study Completion
April 1, 2010
Last Updated
July 16, 2014
Record last verified: 2014-07