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

Lymphoma, B-Cell Clinical Trial

Official title:

Phase II Clinical Trial of Intra-lesional Administration of TG1042 (Adenovirus-Interferon-gamma) in Patients With Relapsing Primary Cutaneous B-Cell Lymphomas.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394693
• Other study ID #: TG1042.06
• Status: Completed
• Phase: Phase 2
• First received: October 31, 2006
• Last updated: July 15, 2014
• Start date: November 2006
• Est. completion date: April 2010

Study information

• Verified date: July 2014
• Source: Transgene
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Switzerland: SwissmedicPoland: Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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, interferona, 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell

Intervention

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

Locations

Country	Name	City	State
France	Hopital Lapeyronie	Montpellier
France	Hopital de l'Hotel-Dieu	Nantes
Switzerland	University Hospital of Zurich	Zurich
United States	Northwestern University Medical School	Chicago	Illinois
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Transgene

Countries where clinical trial is conducted

United States,  France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regression and disappearance of lesions		end of cycle	No
Primary	Safety		visit	Yes
Secondary	Quality of Life		visit	No

External Links

•   Link