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

Condition(s) targeted: Lymphoma, B-Cell

Intervention: Adenovirus Interferon gamma (Genetic)

Phase: Phase 2

Status: Recruiting

Sponsored by: Transgene

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.

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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Regression and disappearance of lesions

Safety

Secondary outcome: Quality of Life

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Institute of Haematology, ZAGREB 10000, Croatia; Recruiting
I RADMAN, MD, Phone: +385 1 238 88 88/277, Email: iradman@net.hr
I RADMAN, MD, Principal Investigator

Hopital de l'Hotel-Dieu, Nantes 44093, France; Recruiting
Brigitte DRENO, M.D., Phone: +33-240-083-116, Email: brigitte.dreno@wanadoo.fr
Brigitte DRENO, M.D., Principal Investigator

Hopital Lapeyronie, Montpellier 34295, France; Recruiting
Jean François ROSSI, M.D., Phone: +33-467-338-079, Email: jf-rossi@chu-montpellier.fr
Jean François ROSSI, M.D., Principal Investigator

Hopital Henri Mondor, Créteil 94010, France; Recruiting
Martine BAGOT, M.D., Phone: +33-149-812-501, Email: martine.bagot@hmn.aphp.fr
Martine BAGOT, M.D., Principal Investigator

Klinika Dermatologii, Wenerologii i Alergologii, Gdańsk 80-952, Poland; Recruiting
Malgorzata Sokolowska-Wojdylo, MD, Phone: +48 (58) 349 25 80, Email: mwojd@amg.gda.pl
Jadwiga ROSZKIEWICZ, Pr, Principal Investigator

Katedra i Klinika Dermatologii Akademii Medycznej w Bydgoszczy, Bydgoszcz 85-096, Poland; Recruiting
Aleksandra Grzanka, MD, Phone: +48 (52) 585-45-68, Email: aleksandrag@op.pl
Waldemar PLACEK, Pr, Principal Investigator

Clinical Centre Serbia, Belgrade 11000, Serbia; Recruiting
Biljana MIHALJEVIC, Pr, Phone: +381 65 2457597, Email: bimih@eunet.yu
Biljana MIHALJEVIC, Pr, Principal Investigator

University Hospital of Zurich, Zurich 8090, Switzerland; Recruiting
Reinhard G. DUMMER, M.D., Phone: +41-44-255-2550, Email: reinhard.dummer@usz.ch
Reinhard G. DUMMER, D.M., Principal Investigator

Stanford University School of Medicine, Stanford, California 94305-5334, United States; Recruiting
Youn H. KIM, M.D., Phone: 650-723-7893, Email: younkim@stanford.edu
Youn H KIM, M.D., Principal Investigator

Northwestern University Medical School, Chicago, Illinois 60611, United States; Recruiting
Joan GUITART, M.D., Phone: 312-695-4174, Email: j-guitart@northwestern.edu
Joan GUITART, M.D., Principal Investigator

M.D. Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Madeleine DUVIC, M.D., Phone: 713-745-1113, Email: mduvic@mdanderson.org
Madeleine DUVIC, M.D., Principal Investigator

Starting date: November 2006
Last updated: October 10, 2008