NCT00107159已完成2 期
A Phase II Study Of Matured Dendritic Cells Pulsed Ex Vivo With 3 Melanoma Cell Line Lysates (IDD-3) in Patients With In-Transit or Metastatic Melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks
研究概览
简要总结
RATIONALE: Vaccines made from a person's white blood cells and a donor's tumor cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with unresected stage III or stage IV melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the clinical activity of vaccine therapy comprising autologous dendritic cells pulsed with allogeneic melanoma tumor cell lysates (IDD-3), as measured by tumor control, in patients with unresected stage IIIB or IIIC or stage IV melanoma.
Secondary
- Determine the immunologic activity of this vaccine, as measured by T-cell and antibody responses to lysate or to melanoma antigens or peptides, in these patients.
- Determine the safety of this vaccine, as measured by the incidence and severity of adverse events, in these patients.
研究设计
- 研究类型
- Interventional
- 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 primary cutaneous or unknown primary melanoma, including 1 of the following stages:
- •Stage IIIB or IIIC disease
- •Unresected, in-transit lymph node metastases (N2c or N3)
- •Stage IV disease
- •Distant skin, subcutaneous, lymph node, or pulmonary metastases (M1a or M1b)
- •No cerebral, bone, or other visceral metastases
- •At least 1 measurable or evaluable lesion
- •Small-volume multiple cutaneous deposits allowed
- •Progressive disease, as defined by 1 of the following criteria:
- •At least 20% increase in size in ≥ 1 measurable or evaluable lesion
- •Appearance of ≥ 1 new lesion since or during last treatment (if applicable) AND within the past 3 months
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
- •SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
- •Lactic dehydrogenase normal
- •No active hepatitis B or C infection
- •Creatinine ≤ 1.5 times ULN
- •Immunologic
- •No history of autoimmune disease
- •Vitiligo allowed
- •No history of immunodeficiency syndrome
- •No active bacterial, viral, or fungal infection within the past 72 hours
- •HIV-1 or -2 negative
- •Human T-cell lymphotrophic virus-I or -II negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No contraindication to apheresis
- •No other significant medical or surgical condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior vaccine therapy with ≥ 1 melanoma antigen or peptide
- •More than 4 weeks since prior biologic therapy
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •Endocrine therapy
- •No concurrent chronic systemic corticosteroids
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy
- •Not specified
- •More than 4 weeks since prior investigational products
- 另有 4 项未显示
排除标准
- 未提供
结局指标
主要结局
Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks
次要结局
- Safety
- Immune response
研究者
研究点 (1)
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