POLYVALENT VACCINE--PHASE III TRIAL IN STAGE IV MELANOMA

描述(申请人的描述)：建议的目标 该项目是为了展示一种活的辐照多价化合物的功效 黑色素瘤细胞疫苗(PMCV)在第三阶段多中心临床试验中 临床诊断为AJCC IV期黑色素瘤患者的检查 外科手术带来的疾病。该项目的具体目标是： 1.进行PMCV的多中心随机双盲III期试验 联合卡介苗与安慰剂+卡介苗作为AJCC IV期的辅助免疫治疗 临床诊断为无疾病的黑色素瘤患者(没有证据表明 疾病(NED))通过手术切除。 2.在外科多中心试验中确定临床结果 IV期黑色素瘤远处转移的切除。 3.确定新的免疫学和分子标志物是否可以用于 检测亚临床转移性黑色素瘤并评估其对佐剂的反应 心理治疗。我们假设这些新技术可以用来预测 影响黑色素瘤患者辅助治疗效果的因素 在手术后。准确识别患者的方法学 亚临床肿瘤负担作为分层因素将非常有用 辅助治疗的临床试验，以及在治疗 个体黑色素瘤患者。 4.制定评估免疫原性和监测对PMCV反应的方法 通过检测针对特定抗体的主动免疫治疗的抗体反应 黑色素瘤相关抗原与皮肤试验反应的诱导 PMCV。确定这些响应与 前瞻性多中心试验中疫苗患者的临床病程。

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.