Education and Training

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

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.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • genetic: Adenovirus Interferon gamma

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, 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.

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Natalie Viakhireva
6507238949
Not Recruiting