Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™
试验速览
- 阶段
- 2 期
- 试验地点
- 22
- 主要终点
- Response
研究概览
简要总结
RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.
详细描述
OBJECTIVES:
- Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™).
OUTLINE: This is an open-label, multicenter study.
Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of response at week 24 receive no further treatment. Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine (Canvaxin™).
After completion of study treatment, patients are followed at 30 days.
研究设计
- 研究类型
- Interventional
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Response
次要结局
未报告次要终点