- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00394693
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- Hôpital Lapeyronie
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Nantes, France, 44093
- Hôpital de l'Hôtel-Dieu
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Zurich, Switzerland, 8090
- University Hospital of Zürich
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California
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Stanford, California, United States, 94305-5334
- Stanford University School of Medicine
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Medical School
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Texas
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Houston, Texas, United States, 77030
- M.D. Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Regression and disappearance of lesions
Time Frame: end of cycle
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end of cycle
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Safety
Time Frame: visit
|
visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of Life
Time Frame: visit
|
visit
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- Accart 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TG1042.06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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