POLYVALENT VACCINE--PHASE III TRIAL IN STAGE IV MELANOMA

描述（申请人的描述）：提出的目的 该项目是为了证明一个活的辐射多价的功效， 黑色素瘤细胞疫苗（PMCV）的III期多中心临床试验 检查AJCC IV期黑色素瘤患者临床上没有 疾病通过手术。 该项目的具体目标是： 1. 开展PMCV多中心随机双盲III期试验 联合BCG与安慰剂联合BCG作为AJCC IV期患者的辅助免疫治疗 黑色素瘤患者在临床上表现为无疾病（没有证据表明 疾病（NED））。 2. 确定外科手术多中心试验的临床结果 切除IV期黑色素瘤的远处转移。 3. 确定新的免疫学和分子标记物是否可用于 检测亚临床转移性黑色素瘤并评估对佐剂的反应 疗法 我们假设这些新技术可以用来预测 黑色素瘤患者辅助治疗结果的预测因素 手术后。 准确识别患者的方法 亚临床肿瘤负荷作为分层因素在 辅助治疗的临床试验，以及在管理 个体黑素瘤患者。 4. 开发评价免疫原性和监测对PMCV应答的方法 通过检测对针对特定的 黑色素瘤相关抗原和皮肤试验应答的诱导 PMCV。 确定这些反应之间是否存在任何相关性， 一项前瞻性多中心试验中疫苗患者的临床过程。

DESCRIPTION (Applicant's Description): The objective of the proposed project is to demonstrate the efficacy of a living irradiated polyvalent melanoma cell vaccine (PMCV) in a Phase III multicenter clinical trial examining AJCC Stage IV melanoma patients rendered clinically free of disease by surgery. This project's specific aims are: 1. Conduct a multicenter randomized double-blind Phase III trial of PMCV plus BCG versus placebo plus BCG as adjuvant immunotherapy in AJCC Stage IV melanoma patients rendered clinically free of disease (no evidence of disease (NED)) by surgical resection. 2. Determine the clinical results in a multicenter trial of surgical resection of distant metastases in Stage IV melanoma. 3. Determine whether new immunological and molecular markers can be used to detect subclinical metastatic melanoma and evaluate the response to adjuvant therapy. We hypothesize that these new techniques can be used as prognostic factors in predicting the outcome of adjuvant therapy for melanoma patients following surgery. Methodology to accurately identify patients with subclinical tumor burden would be very useful as stratification factors in clinical trials of adjuvant therapy, as well as in the management of the individual melanoma patient. 4. Develop methods to evaluate immunogenicity and monitor responses to PMCV by detecting antibody responses to active immunotherapy against specific melanoma-associated antigens and the induction of skin test responses to PMCV. Determine whether there is any correlation between such responses and the clinical course of vaccine patients in a prospective multicenter trial.