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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphoma, B-Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Adenovirus Interferon gamma

intra-tumoral injections, 1 dose per lesion, up to 6 simultaneous lesions.

Intervention Type GENETIC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No