NCT00334776已完成2 期
A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.
详细描述
OBJECTIVES:
Primary
- Determine clinical response in HLA-A *0201-positive patients with metastatic melanoma treated with an intradermally administered vaccine comprising autologous dendritic cells pulsed with MART-1, gp100, and tyrosinase peptides and matured with a cytokine cocktail.
Secondary
- Determine immunologic response in patients treated with this regimen.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of melanoma
- •Metastatic disease
- •The following melanoma subtypes are eligible:
- •Unresectable, stage III-IV uveal melanoma
- •Metastatic mucosal melanoma
- •Measurable disease after attempted curative surgical therapy
- •Tumor tissue must be available for immunohistochemical staining
- •Positive for ≥ 1 of the following peptides:
- •MART-1: 26-35 (27L)
- •gp100: 209-217 (210M)
- •Tyrosinase: 368-376 (370D)
- •HLA-A *0201 positive by DNA polymerase chain reaction assay
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- •Creatinine ≤ 2.0 mg/dL
- •Bilirubin ≤ 2.0 mg/dL
- •WBC ≥ 3,000/mm^3
- •Platelet count ≥ 75,000/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •No major systemic infections
- •No coagulation disorders
- •No major medical illness of the cardiovascular or respiratory system
- •No myocardial infarction within the past 6 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known HIV positivity
- •No know positivity for hepatitis B surface antigen or hepatitis C antibody
- •No prior uveitis or autoimmune inflammatory eye disease
- •No other prior malignancy except cervical carcinoma in situ or basal cell skin cancer unless patient was curatively treated > 5 years ago and has no detectable disease
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No more than 1 prior cytotoxic chemotherapy agent or regimen
- •Prior biologic or antiangiogenic therapies allowed
- •More than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant therapy, or any other therapy for melanoma
- •No prior MART-1: 26-35 (27L), gp100: 209-217 (210M), or tyrosinase: 368-376 (370D) peptides
- •No concurrent steroid therapy
排除标准
- 未提供
结局指标
主要结局
Overall survival
Progression-free survival
Time to progression
Toxicity
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Vaccine Therapy in Treating Patients With Liver CancerLiver CancerNCT00022334Jonsson Comprehensive Cancer Center33
已完成
2 期
Vaccine Therapy and GM-CSF in Treating Patients With Recurrent or Metastatic MelanomaMelanoma (Skin)NCT00436930Hoag Memorial Hospital Presbyterian200
已完成
2 期
Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV MelanomaMelanoma (Skin)NCT00107159Jonsson Comprehensive Cancer Center37
已完成
1 期
Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant GliomaBrain and Central Nervous System TumorsNCT00107185Jonsson Comprehensive Cancer Center7
Unknown
2 期
Vaccine Therapy With or Without Fludarabine in Treating Patients With Stage IV Kidney CancerKidney CancerNCT00093522St. Luke's Medical Center28