Gene Transfer for Intractable Pain: A Phase I Clinical Trial to Determine the Maximum Tolerable Dose of a Replication-Defective Herpes Simplex Virus Type I (HSV-1) Vector Expressing Human Preproenkephalin (NP2) in Patients With Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Diamyd Inc
- 入组人数
- 10
- 试验地点
- 5
- 主要终点
- Safety measured by vital signs, physical exam findings, clinical laboratory analyses and treatment related Adverse Events (AE).
研究概览
简要总结
The primary purpose of this study is to examine the safety of NP2 (a nonreplicating HSV-based vector expressing enkephalin) in patients with cancer pain. The secondary purpose is to evaluate efficacy.
详细描述
Therapeutic HSV-based vectors deliver genes from skin inoculation to sensory neurons to interrupt pain signaling at the spinal level. Side effects may be limited by the focal distribution of vector delivery and preproenkephalin expression. Preproenkephalin is a natural human gene that produces peptides that bind to opioid receptors in the body. The therapeutic being evaluated, NP2, is a replication defective herpes simplex type 1 virus (HSV-1) modified to express the human preproenkephalin gene that has demonstrated efficacy in numerous model of pain, including pain caused by cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with intractable pain from malignant disease with a 5 year projected survival of less than 25%.
- •Female patients of childbearing potential who have a negative pregnancy test and using birth control.
- •Patients who have not received recent treatment with a radiation, chemotherapeutic or immunotherapeutic agent and are not expected to undergo such treatment 28 days after injection of NP
- •Patients who have not had surgical stabilization/resection within 4 weeks of Screening and have no plans for additional surgical procedures.
- •Patients with adequate bone marrow function, IgG levels greater than 565 mg% and CD4 count greater than
排除标准
- •Patients with serious uncontrolled medical conditions other than malignancy.
- •Patients with severe liver or renal impairment
- •Patients currently or previously with positive serology for HIV, Hepatitis B or Hepatitis C.
- •Patients with a hemoglobin <9 gm% or uncontrolled coagulopathy or bleeding diathesis.
- •Patients with a clinical diagnosis of any active herpes infection within the past 6 months.
- •Patients who have been vaccinated to prevent HSV infection or a history of shingles or the presence of active shingles.
研究组 & 干预措施
NP2
Intradermal injection
干预措施: NP2 (Biological)
结局指标
主要结局
Safety measured by vital signs, physical exam findings, clinical laboratory analyses and treatment related Adverse Events (AE).
时间窗: 4 Months
次要结局
- Evaluate changes in cancer-related pain(4 Months)