ACTIVE SPECIFIC IMMUNOTHERAPY FOR MELANOMA

黑色素瘤的主动特异性免疫治疗

• 批准号: 6581147
• 负责人: DONALD L MORTON
• 金额: $ 5.34万
• 依托单位: SAINT JOHN'S CANCER INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-04-15 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6581147
• 关键词: Mycobacterium bovis; colony stimulating factor; human subject; human therapy evaluation; immunomodulators; interleukin 12; melanoma; neoplasm /cancer immunology; neoplasm /cancer immunotherapy; neoplasm /cancer vaccine; patient oriented research; tumor antigens

DESCRIPTION (provided by applicant): The long-term objective of this grant has been the development of effective therapeutic vaccines against malignant melanoma. The Project's focus is the evaluation of a living irradiated polyvalent melanoma cell vaccine (PMCV). This project has four Specific Aims: 1) We will conduct a multicenter randomized Phase III trial in AJCC Stage III melanoma to test the hypothesis that PMCV plus BCG has superior activity in prolonging disease free and overall survival when compared to placebo plus BCG as a post surgical adjuvant. 2) Determine the immune response that optimally correlates with the clinical outcome of PMCV recipients enrolled in the Phase III trial. Our goal is to develop an immune response model that can serve as a prototype for monitoring vaccine therapy in patients with melanoma. 3) Determine whether the immune response against tumor-associated antigens can be enhanced by combining PMCV immunotherapy with cytokines that are effective vaccine adjuvants for inducing tumor rejection responses in animal models, such as GMCSF and IL-12 and whether manipulation of co-stimulatory molecules on melanoma cells can enhance immmunogenicity. 4) To determine whether new tumor markers can be used to detect subclinical metastatic melanoma and quantitate the response to adjuvant therapy. We hypothesize that these new techniques will be useful in predicting the outcome of adjuvant therapy for melanoma patients who have no clinical evidence of disease following sugery.

描述（由申请人提供）：本补助金的长期目标 一直是开发有效的治疗性疫苗， 黑素瘤该项目的重点是评估受辐照的活体 多价黑色素瘤细胞疫苗（PMCV）。该项目有四个具体目标： 1)我们将在AJCC III期进行一项多中心随机III期试验 PMCV + BCG在黑色素瘤中具有上级活性， 与安慰剂加BCG相比，延长无病生存期和总生存期 作为术后辅助剂2)确定免疫反应， 与入组阶段的PMCV接受者的临床结局相关 第三次审判。我们的目标是开发一种免疫反应模型， 一个用于监测黑色素瘤患者疫苗治疗的原型。 3)确定针对肿瘤相关抗原的免疫应答是否 可以通过将PMCV免疫疗法与细胞因子结合来增强， 用于在动物中诱导肿瘤排斥反应有效疫苗佐剂 模型，如GMCSF和IL-12，以及是否操纵共刺激因子， 黑色素瘤细胞上的分子可以增强免疫原性。4)以确定 新的肿瘤标志物是否可用于检测亚临床转移 黑色素瘤并定量对辅助治疗的反应。我们假设 这些新技术将有助于预测佐剂的结果， 用于没有疾病临床证据的黑色素瘤患者的治疗 在sugery之后。