A Randomized, Controlled Trial of Melanoma Treatment: Comparison of Dendritic Cells Versus Montanide as Adjuvants to Stimulate Anti-tumor Immunity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Immunology
研究概览
简要总结
In this study, a melanoma vaccine (5 melanoma peptides) is given with either Montanide or dendritic cells as adjuvants. This randomized trial will establish the safety of both vaccines and compare the 2 vaccine adjuvants in their efficacy to induce immune responses.
详细描述
In this study, we will examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens in melanoma patients who are clinically free of disease but at high risk for recurrence. This vaccine will be compared to direct injection of the same peptides with KLH and Montanide as adjuvant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Resected stage IIB, IIC, or stage III melanoma.
- •Fully recovered from surgery
- •Human leukocyte antigen (HLA) A*0201 positive.
- •Age >18 years.
- •Karnofsky performance status: >80% and normal labs.
排除标准
- •Prior chemotherapy.
- •Known chronic infection with HIV, hepatitis B or C.
- •Patients with known autoimmune disease [e.g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA)]. Patients with vitiligo are not excluded.
- •Pregnant women.
- •Patients with known allergy to gentamicin, tobramycin, streptomycin and amikacin (risk of cross-reaction between aminoglycosides).
- •Patients who have known retinal or choroidal eye disease.
- •Patients previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with Montanide are not eligible.
- •Allergy to shellfish.
研究组 & 干预措施
1
KLH and peptide pulsed DCs
干预措施: KLH; Peptides; Dendritic Cells (Drug)
2
KLH, peptides plus Montanide
干预措施: KLH, peptides plus Montanide (Drug)
结局指标
主要结局
Immunology
时间窗: Examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens
次要结局
- Safety(Post drug administration)
研究者
Dr. Nina Bhardwaj
Director, Tumor Vaccine Program
Bhardwaj, Nina, M.D.