Transcutaneous (Topical) Peptide Immunization With NY-ESO-1b (SLLMWITQC) Peptide Using Resiquimod as an Immune Adjuvant: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Toxicity profile of each dose level
研究概览
简要总结
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with resiquimod may make a stronger immune response and prevent or delay the recurrence of cancer.
PURPOSE: This clinical trial is studying the side effects, best dose, and best way to give vaccine therapy together with resiquimod in treating patients with stage II, stage III, or stage IV melanoma that has been completely removed by surgery.
详细描述
OBJECTIVES:
- Determine the safety and immunization efficacy of the NY-ESO-1b peptide vaccine with resiquimod adjuvant in patients with completely resected stage II-IV melanoma.
- Collect, preliminarily, descriptive data on the impact of this regimen on time to melanoma relapse in these patients.
OUTLINE: This is a 3-step pilot, dose-escalation study of resiquimod.
- Step 1: Patients receive NY-ESO-1b peptide vaccine intradermally and topical resiquimod on day 1.
A cohort of 3-6 patients receives a maximal dose of resiquimod with NY-ESO-1b peptide vaccine.
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
- 18 Years 至 —（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
研究组 & 干预措施
Immunization with NY-ESO-1b
Efficacy of maximal dose of topical resiquimod as immune adjuvant to intradermally administered NY-ESO-1b peptide vaccine.
干预措施: resiquimod (Drug)
结局指标
主要结局
Toxicity profile of each dose level
时间窗: 4 weeks
Number and severity of hematologic and non-hematologic toxicities
时间窗: 4 weeks
Percent of patients who mount an immune response
时间窗: 4 weeks
次要结局
未报告次要终点