NCT00053391已完成1 期
Vaccination Of HLA-A1 And/Or -A2+ Stage III or IV Melanoma Patients With Tumor Peptide - Loaded Autologous Dendritic Cells That Are Generated In The Absence Or Presence Of CD40 Ligand
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Comparison of the efficacy of vaccination with vs without ex vivo CD40-ligand in terms of tumor-specific T-cell response
研究概览
简要总结
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV melanoma.
详细描述
OBJECTIVES:
- Compare the efficacy of vaccination with autologous dendritic cells pulsed with tumor and influenza antigen peptides treated with vs without ex vivo CD40-ligand, in terms of tumor-specific T-cell response, in patients with HLA-A1 and/or HLA-A2.1 positive stage III or IV melanoma.
- Determine the safety and tolerability of these vaccinations in these patients.
- Determine tumor response and recurrence rates in patients treated with these vaccinations.
OUTLINE: This is an open-label non-randomized study.
- Phase I: Patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMC). PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 to generate dendritic cells (DCs) on day -9. DCs are pulsed separately with HLA-A1 and HLA-A2.1-restricted flu matrix peptides derived from melanoma-associated tumor antigens (MAGE-10.A2, Melan-A, MAGE-3, NY-ESO-1, gp100 antigen, and tyrosinase peptide). Half of the DCs are treated ex vivo with CD40-ligand. Patients receive the peptide-pulsed DC vaccinations subcutaneously (SC) on days 1, 14, 42, and 70 in the absence of disease progression.
Patients who show tumor response (at least stable disease) at day 98 progress to phase II of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage III or IV cutaneous malignant melanoma
- •HLA-A1 and/or HLA-A2 expression by serologic HLA typing
- •HLA-A2.1 subtype must be confirmed by polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells
- •No active CNS metastases by CT scan or MRI
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •At least 4 months
- •Hematopoietic
- •WBC greater than 2,500/mm^3
- •Neutrophil count greater than 1,000/mm^3
- •Lymphocyte count greater than 700/mm^3
- •Platelet count greater than 75,000/mm^3
- •Hemoglobin greater than 9 g/dL
- •No bleeding disorders
- •Bilirubin less than 2.0 mg/dL
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •Creatinine less than 2.5 mg/dL
- •Cardiovascular
- •No clinically significant heart disease
- •No clinically significant respiratory disease
- •Immunologic
- •No active systemic infection
- •No immunodeficiency disease
- •No evidence of HIV-1, HIV-2, or human T-cell lymphotropic virus-1
- •No active autoimmune disease including (but not limited to):
- •Lupus erythematosus
- •Autoimmune thyroiditis or uveitis
- •Multiple sclerosis
- •Inflammatory bowel disease
- •Stable medical condition
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 1 month after study participation
- •No organic brain syndrome or psychiatric illness that would preclude study compliance
- •No other concurrent active malignancy
- •No other concurrent serious illness that would preclude study treatment
- •No contraindication to leukapheresis
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior immunotherapy
- •No other concurrent immunotherapy
- •Chemotherapy
- •More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas)
- •No concurrent chemotherapy
- •Endocrine therapy
- •No concurrent corticosteroids
- 另有 10 项未显示
排除标准
- 未提供
结局指标
主要结局
Comparison of the efficacy of vaccination with vs without ex vivo CD40-ligand in terms of tumor-specific T-cell response
Safety
Tolerability
次要结局
- Recurrence rates
- Tumor response
研究者
PD Dr. med. univ. Beatrice Schuler-Thurner
Prinicipal Investigator Prof. Dr. Schuler Gerold
University Hospital Erlangen
研究点 (1)
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