A Phase II Study of an Anti-Tumor Immunotherapy Regimen Comprised of Pegylated Interferon-Alpha 2b (PEG-Intron)and HyperAcute Melanoma Vaccine for Subjects With Advanced Melanoma
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To conduct scientific studies of patient tumor and peripheral blood samples to determine the mechanism of any observed anti-tumor effect involving the immune responses to the HyperAcute® vaccine alone & combined with PEG-Intron
研究概览
简要总结
The purpose of this study is to determine the safety of giving subjects with advanced, recurrent or refractory melanoma the HyperAcute® Melanoma vaccine with a variant of a drug, called Interferon (PEG-Intron®) that is specially formulated to be given on a weekly basis (instead of daily). The study vaccine (HyperAcute®-Melanoma) is made from three types of human melanoma cell lines (grown in the laboratory) in which the genes have been slightly changed. This clinical study will try to discover the safety of the study vaccine combined with PEG-Intron®, its side effects and the potential benefits, if any.
详细描述
This study will look at the anti-tumor vaccine effect, side effects and toxicity of the HyperAcute® Vaccine with PEG-Intron®. It is hoped that the immune system's response to these genetically engineered melanoma cells and PEG-Intron® will cause a reaction that will make it react to and attack and kill the melanoma cells and keep it from growing, possibly causing the tumors to shrink.
Patients that are eligible are 19 years or older and have been diagnosed with advanced, treatment resistant or recurrent melanoma, an aggressive usually pigmented form of skin cancer.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years or older
- •Histological diagnosis of melanoma
- •AJCC Stage IIIC (any T, N1b, N2b, N3, M0) or Stage IV (any T, and N, M1), metastatic, progressive, refractory, recurrent or high risk of recurrence melanoma.
- •Expected survival of more than 6 months
- •Adequate organ function
- •Measurable or non-measurable disease
- •Must have negative serologies for Hepatitis B and C and HIV prior to entering study
- •Must be more than 4 weeks since major surgery, radiotherapy, chemotherapy or biotherapy/targeted therapies
- •Male and female subjects of child producing potential must agree to use contraception or avoidance pregnancy measures while enrolled on the study and for one month after the last immunization.
排除标准
- •Active CNS metastases or carcinomatous meningitis
- •Hypercalcemia
- •Pregnant or nursing women
- •Other malignancy within five years
- •History of organ transplant or current active immunosuppressive therapy
- •Subjects taking systemic corticosteroid therapy
- •Active infection or antibiotics within 1-week prior to study
- •Uncontrolled or significant congestive heart failure, myocardial infarction, ventricular arrhythmias or pulmonary dysfunction
- •Autoimmune disease
- •A known allergy to any component of the HyperAcute vaccine or PEG-Intron
- •Patients having undergone splenectomy
- •Patients with sickle-cell anemia or thalassemia major.
结局指标
主要结局
To conduct scientific studies of patient tumor and peripheral blood samples to determine the mechanism of any observed anti-tumor effect involving the immune responses to the HyperAcute® vaccine alone & combined with PEG-Intron
时间窗: 2 years
次要结局
- To determine the safety and response rate of the administration of the HyperAcute®-Melanoma Vaccine combined with PEG-Intron® into patients with recurrent, refractory, metastatic, or high risk of recurrence melanoma(2 years)