A Phase II Trial of a MART-1/gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated With CD40 Ligand/Gamma Interferon With Subcutaneous IL-2 for Patients With Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.
详细描述
OBJECTIVES:
- Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in vivo.
- Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4, sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic melanoma
- •Measurable disease after attempted curative surgery
- •Unresectable stage III or IV uveal melanoma
- •Metastatic mucosal melanoma
- •HLA-A2.1 positive
- •No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg every 8 hours)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 75,000/mm^3
- •Hemoglobin at least 9.0 g/dL
- •No coagulation disorders
- •Bilirubin no greater than 2.0 mg/dL
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No myocardial infarction within the past 6 months
- •Patients with documented or suspected coronary artery disease must undergo stress thallium test
- •No major cardiovascular illness
- •No major pulmonary illness
- •Immunologic:
- •HIV negative
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •No history of uveitis or autoimmune inflammatory eye disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No major systemic infection
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •No prior MART-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens
- •Chemotherapy:
- •At least 1 month since prior chemotherapy for melanoma
- •Endocrine therapy:
- •No concurrent steroid therapy
- •Radiotherapy:
- •At least 1 month since prior radiotherapy for melanoma
- •See Disease Characteristics
- •At least 1 month since prior adjuvant therapy for melanoma
- •At least 1 month since other prior therapy for melanoma
排除标准
- 未提供