INTERFERON ENHANCED CC49 MONOCLONAL ANTIBODY IN METASTATIC PROSTATE CANCER

这项研究旨在确定一种抗体(CC49)是否已经被 用放射性核素(131)标记并注射到静脉中，将结合 主要是肿瘤，而不是正常组织，允许检测到 这些肿瘤通过扫描和治疗性放射治疗。这 放射性标记抗体131I-CC49是一种研究试剂。这个 与抗体结合的放射性比使用的大 进行诊断性扫描，希望治疗剂量的辐射可以 被选择性地输送到肿瘤部位。131I-抗体将是 注射一次，作为一个疗程。干扰素，一种治疗 刺激细胞表达CC49抗体反应的物质 与，将给予前后的抗体。 这项研究对前列腺癌患者开放。 在进入这项研究之前，血液将进行检测，以确定是否存在 人类免疫缺陷病毒抗体和乙肝表面抗原。 在接受抗体前两天(每天持续两次 几周后)，患者将获得卢戈尔碘溶液， 将有助于防止放射性碘进入甲状腺； 甲状腺激素药丸也会用来抑制甲状腺。论 在抗体输注当天，患者将被给予一剂 非放射性抗体，观察过敏反应。如果有 过敏反应，患者不会进行这项研究。 在注射放射性抗体后，患者将被 必须待在病房里，直到辐射量达到 降低到不会使其他人接触到显著 风险(大约5天)。 毒性和反应将由实验室和临床监测 标准，并在适当的情况下增加放射学评估。

This study is designed to determine if an antibody (CC49) which has been labeled with the radionuclide (131) and injected into a vein, will bind primarily to tumors but not to normal tissues, allowing detection of these tumors by scanning and a therapeutic delivery of radiation. This radiolabeled antibody, 131I-CC49, is an investigational agent. The amount of radioactivity bound to the antibody is larger than that used for diagnostic scanning in hopes that therapeutic doses of radiation can be selectively delivered to the tumor sites. The 131I-antibody will be injected once, as one treatment course. Interferon, an agent to stimulate cells to express the substance that the CC49 antibody reacts with, will be given before and after the antibody. This study is open to patients with adenocarcinoma of the prostate. Prior to entry into the study, blood will be tested for the presence of human immunodeficiency virus antibody and hepatitis B surface antigen. Two days prior to receiving the antibody (and continuing daily for two weeks thereafter), patients will receive a Lugol's iodine solution that will help keep the radioactive iodine from going to the thyroid; a thyroid hormone pill to suppress the thyroid will also be used. On the day of antibody infusion, patients will be given a dose of non-radioactive antibody and observed for allergic reaction. If there is allergic reaction, patients will not go on this study. After the radioactive antibody has been injected, patients will be required to stay in the hospital room until the amount of radioactivity decreases to a level which will not expose other people to significant risk (approximately 5 days). Toxicity and response will be monitored by laboratory and clinical criteria with the addition of radiographic evaluation when appropriate.