0430 GCC

0430 海湾合作委员会

• 批准号: 7608141
• 负责人: RICHARD B ALEXANDER
• 金额: $ 0.28万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608141
• 关键词: Adjuvant; Amino Acid Sequence; Amino Acids; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dose; End Point; Enrollment; Funding; Grant; HLA-A2 Antigen; Immunologics; Institution; Laboratories; Malignant neoplasm of prostate; Montanide ISA-51; Numbers; Outcome; Patients; Peptides; Phase; Radical Prostatectomy; Research; Research Personnel; Resources; Site; Source; Staging; Toxic effect; United States National Institutes of Health; Week; design; pilot trial; serum PSA; vaccination strategy

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. We propose a clinical trial of the peptide PSA: 154-163(155L) (amino acid sequence VLSNDVCAQV representing residues 154-163 (155L) of mature secreted PSA sequence numbered without the 24 amino acid leader sequence) as a vaccination strategy for the treatment of prostate cancer in HLA-A2 patients with detectable and rising serum PSA after radical prostatectomy. The trial will be a single dose-level, Phase II pilot trial of 1 mg of PSA: 154-163(155L) emulsified with adjuvant (Montanide¿ ISA-51) given subcutaneously at 2 sites every other week x 4, then every 4th week x 3. The primary outcome will be determination of immunologic laboratory endpoints, secondary outcomes will be determination of toxicity and effect on serum PSA. The trial is a two-stage design with 18 patients enrolled in the first stage. After an interim analysis an additional 14 patients will be treated if the peptide PSA: 154-163(155L) remains promising.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以出现在其他 CRISP 条目中 列出的机构是。 对于中心来说，它不一定是研究者的机构。 我们建议对肽 PSA：154-163(155L)（氨基酸序列 VLSNDVCAQV 代表成熟分泌 PSA 序列的残基 154-163 (155L)，编号不含 24 个氨基酸前导序列）进行临床试验，作为治疗的疫苗接种策略根治性前列腺切除术后血清 PSA 可检测到且上升的 HLA-A2 患者中前列腺癌的临床试验将是单剂量水平的 II 期试验。 1 mg PSA 的试点试验：154-163(155L) 与佐剂 (Montanide¿ ISA-51) 乳化，在 2 个部位皮下注射，每隔一周 x 4，然后每 4 周 x 3。主要结果将是免疫学测定实验室终点、次要结果将是确定毒性和对血清 PSA 的影响。该试验采用两阶段设计，第一阶段招募了 18 名患者。中期分析表明，如果肽 PSA：154-163(155L) 仍然有希望，将另外治疗 14 名患者。