NCT00698100已完成1 期
Vaccination of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Human and Mouse Tyrosinase DNA Vaccines: A Phase I Trial to Assess Safety and Immune Response
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Is to determine the safety and immunogenicity of vaccination with the genes coding for mouse and human tyrosinase in patients.
研究概览
简要总结
The overall goal of this study is to find out about the safety of injecting the genes (DNA) for human and mouse tyrosinase in patients with melanoma. There is no evidence yet that injection of tyrosinase DNA results in any clinical benefit. Tyrosinase is the substance found in melanoma cells that helps to produce their black color. The DNA used in this study was purified from bacteria which contains the gene for tyrosinase. DNA is material which contains the information needed to produce many substances in the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patients must have documented malignant melanoma, American Joint Commission on Cancer (AJCC) stage IIB, IIC, III or IV. Patients free of disease after surgical resection will also be eligible.
- •For all patients, pathology slides must be reviewed by the Memorial Hospital Department of Pathology for confirmation of melanoma diagnosis.
- •Patients must be HLA-A0201 positive.
- •Patients must be at least 18 years of age to be eligible and must be able to read the informed consent and give informed consent.
- •Patients must have a Karnofsky performance status of at least
- •LDH < than or = to 2x upper limit of normal value; albumin > than or = to 3.5 mg/dl.
- •A CBC prior to vaccination with WBC > or = to 3000, platelets > or = to 100,
- •Patients must be free of detectable brain metastases.
排除标准
- •Patients may not be receiving or have received chemotherapy, immunotherapy or radiation therapy within the previous 4 weeks. Patients must be fully recovered from any previous therapy or surgery.
- •Patients may not have been previously immunized with vaccines containing tyrosinase or peptides derived from tyrosinase.
- •Any medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators.
- •Patients who have preexisting retinal or choroidal eye disease will be excluded.
- •Patients with serious underlying medical conditions, active infections requiring antimicrobial drugs, or active bleeding will be ineligible.
- •Pregnant women or women who are less than 3 months post-partum are not eligible. Women who may yet bear children and sexually active men must be using appropriate contraception during the course of this study. Women of child-bearing potential must not be pregnant (negative BHCG within 2 weeks of vaccination) nor be nursing during treatment.
结局指标
主要结局
Is to determine the safety and immunogenicity of vaccination with the genes coding for mouse and human tyrosinase in patients.
时间窗: conclusion of the study
次要结局
- To evaluate antibody and CD8+ T cell responses to human tyrosinase after vaccination.(conclusion of the study)
- Is to observe the patients for evidence of any anti-tumor response, which is generated after vaccination.(conclusion of the study)
研究者
研究点 (1)
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