Clinical trial NCT00394693: Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-cell Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, B-Cell
Keywords: 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
Lead sponsor: Transgene
Sponsor class: INDUSTRY
First posted: 2006-11-01
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Regression and disappearance of lesions
timeFrame: end of cycle
measure: Safety
timeFrame: visit
Secondary outcomes:
measure: Quality of Life
timeFrame: visit
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Chicago
country: United States
facility: Northwestern University Medical School
state: Illinois
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: Montpellier
country: France
facility: Hopital Lapeyronie
city: Nantes
country: France
facility: Hopital de l'Hotel-Dieu
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
References:
citation: 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.
citation: 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.