A Phase I Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of Lymfactin® (AdAptVEGF-C Adenoviral Vector) in Combination With a Surgical Lymph Node Transfer for the Treatment of Patients With Secondary Lymphedema
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Biodistribution of Lymfactin in blood
研究概览
简要总结
Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast Cancer.
Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer.
详细描述
This is an open label, multi-center, uncontrolled first in human trial that uses a standard 3 + 3 dose escalation scheme. Lymfactin® will be administered as a single dose by ex vivo perinodal injection into the fat pad of a flap of tissue containing lymph nodes from the abdominal wall. This flap of tissue will then be surgically implanted into the axillary region of the affected arm. This treatment with Lymfactin® may be performed in conjunction with or without breast reconstruction surgery.
Up to two dose cohorts are planned to be included. Each dose of Lymfactin® will be administered as a single dose via perinodal injection in a volume of 2 mL:
- Cohort 1: Lymfactin® [1 x 10E10 vp]
- Cohort 2: Lymfactin® [1 x 10E11 vp]
Should the dose escalation go up to Cohort 2 with initiation of a subsequent Extension Cohort a total of 15 - 21 patients may be treated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lymfactin® [1 x 10E10 vp]
Lymfactin® [1 x 10E10 vp] will be administered as a single dose via perinodal injection in a volume of 2 mL.
干预措施: Lymfactin® [1 x 10E10 vp] (Drug)
Lymfactin® [1 x 10E11 vp]
Lymfactin® [1 x 10E11 vp] will be administered as a single dose via perinodal injection in a volume of 2 mL.
干预措施: Lymfactin® [1 x 10E11 vp] (Drug)
结局指标
主要结局
Biodistribution of Lymfactin in blood
时间窗: 90 days
Changes in Lymfactin genome copy number in blood
CT scan of chest and abdomen
时间窗: baseline, yearly up to 5 years
Changes in the CT scan of chest and abdomen in order to detect malignancies
Safety as measured by number of patients with treatment related adverse events and serious adverse events as assessed by CTCAE v4.0
时间窗: baseline to 1 year, yearly up to 5 years
Adverse events and serious adverse events assessed by CTCAE v4.0 to evaluate the safety profile after administration of Lymfactin
Formation of anti-Lymfactin antibodies
时间窗: 6 months
Changes in the anti-Lymfactin antibody titer in blood
次要结局
- Measurement of the volume of the arms(baseline, 6, 12, 24 and 36 months)
- Measurement of the lymphatic flow of the affected arm by quantitative lymphoscintigraphy (99Tc-nanocolloid clearance rate with calculation of transport index)(baseline, 12, 24 and 36 months)
- Questionnaire according to the Lymphedema Quality of Life Inventory (LQOLI)(baseline, 6, 12, 24 and 36 months)