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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Lymphoma, B-Cell

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Regression and disappearance of lesions

Outcome Time Frame:

end of cycle

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

TG1042.06

NCT ID:

NCT00394693

Start Date:

November 2006

Completion Date:

April 2010

Related Keywords:

  • Lymphoma, B-Cell
  • 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
  • Lymphoma
  • Lymphoma, B-Cell

Name

Location

Stanford University School of MedicineStanford, California  94305-5317
Northwestern University Medical SchoolChicago, Illinois  60611-2927
M.D. Anderson Cancer CenterHouston, Texas  77030