0430 GCC

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者的研究机构。 我们提出了一项临床试验的肽PSA：154-163（155 L）（氨基酸序列VLSNDVCAQV代表残基154-163（155 L）的成熟分泌型PSA序列编号没有24个氨基酸的前导序列）作为一种疫苗接种策略，用于治疗HLA-A2患者的前列腺癌，可检测和血清PSA升高的根治性前列腺切除术后。本试验将是一项单剂量水平的II期初步试验，在2个部位皮下注射1 mg PSA：154-163（155 L）与佐剂（Montanide <$伊萨-51）乳化，每隔一周× 4次，然后每隔4周× 3次。主要结局是确定免疫学实验室终点，次要结局是确定毒性和对血清PSA的影响。该试验为两阶段设计，第一阶段入组18例患者。在中期分析后，如果肽PSA：154-163（155 L）仍然有希望，则将治疗另外14名患者。

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.