NCT00394693已完成2 期
Phase II Clinical Trial of Intra-lesional Administration of TG1042 (Adenovirus-Interferon-gamma) in Patients With Relapsing Primary Cutaneous B-Cell Lymphomas.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Transgene
- 入组人数
- 13
- 试验地点
- 12
- 主要终点
- Regression and disappearance of lesions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Regression and disappearance of lesions
时间窗: end of cycle
Safety
时间窗: visit
次要结局
- Quality of Life(visit)
研究者
研究点 (12)
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