Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Placing the gene for interleukin-12 into breast cancer cells may help the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in treating women with metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine the toxicity and maximum tolerated dose of intratumoral injection of adenovirus-mediated human interleukin-12 gene in women with metastatic breast cancer.
- Determine the tumor response in patients treated with this regimen.
- Determine the immune response in patients treated with this regimen.
OUTLINE: Patients receive a single dose of adenovirus-mediated human interleukin-12 intratumorally via percutaneous needle placement under ultrasound guidance.
Blood and tumor tissue samples are collected periodically for immunological laboratory studies. Samples are analyzed for serum cytokine levels by ELISA; qualitative analysis of immune biomarkers by IHC staining; and immune cell biomarker analysis by FACS.
After completion of study therapy, patients are followed periodically.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
- •Malignant disease in the skin, chest wall, or other sites (lymph nodes or primary tumor in the breast) accessible to percutaneous needle placement and injection
- •Solitary or multiple tumors
- •Measurable disease in ≥ 2 dimensions by physical examination or CT/MRI scan
- •Malignant tumors in the skin and chest wall must be ≥ 4 mm in diameter by physical examination
- •Malignant tumors in other accessible sites must be ≥ 1 cm in diameter on physical examination
- •Malignant disease in other organs (in addition to skin or chest wall metastases) allowed
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •Karnofsky performance status 70-100%
- •Life expectancy ≥ 16 weeks
- •Granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9.0 mg/dL
- •PT normal
- •Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min
- •Serum total bilirubin ≤ 2.0 times upper limit of normal (ULN)
- •Serum transaminases ≤ 2.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Weight ≥ 30 kg (for patients treated with the highest dose level of study drug)
- •No active infection or concurrent serious medical illness
- •No HIV positivity
- •No other malignancy within the past 5 years except for the following:
- •Inactive nonmelanoma skin cancer
- •In situ carcinoma of the cervix
- •Grade 1 papillary bladder cancer
- •PRIOR CONCURRENT THERAPY:
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •No anticoagulant therapy with heparin or warfarin for ≥ 2 months after completion of study treatment
排除标准
- 未提供
研究组 & 干预措施
adenovirus-mediated human interleukin-12
starting dose of ADV-hIL12 - 1 x 10 to the 10th power vp (virus particles) per patient, escalating in half-log increments up to 1 x 10 to the 13th power vp per patient, after which dose escalation will be at lower increments of 2 x 10 to the 13th power vp, to a maximum of 3.0 x 10 to the 13th power vp per patient.
干预措施: adenovirus-mediated human interleukin-12 (Biological)
结局指标
主要结局
Maximum tolerated dose
时间窗: up to 1 month
Serum antibodies (titer) to adenovirus
Toxicity and safety
时间窗: up to 2 months
adverse events as assessed by NCI CTCAE v3.0
次要结局
- Tumor response progression)(up to 2 months)
- Immune response(up to 2 months)
研究者
Max Sung
Associate Professor
Icahn School of Medicine at Mount Sinai