CLINICAL TRIAL: A PH II STUDY OF CNTO 328 ANTIBODY AGAINST IL-6 IN PTS WITH PROS

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所在的机构。 目的： 本研究的主要目的是评估接受CNTO 328治疗的激素难治性D2前列腺癌患者中确认的PSA缓解。 本研究的次要目的包括： a. 评估该组患者的总生存期和无进展生存期。 B. 评估具有可测量疾病的患者的客观缓解率（确认和未确认的完全缓解和部分缓解）。 C. 评价该方案的定性和定量毒性。 D. 初步研究临床研究结果与抗IL 6活性潜在标志物的相关性。 e. 初步研究临床研究结局与C-反应蛋白纵向测量值的相关性。 研究：这项研究的目的是找出新药CNTO 328对前列腺癌有什么影响（好的和坏的）。 CNTO 328是一种新的抗癌药物，可以阻断白细胞介素-6（IL-6），这是一种血液中有助于癌细胞生长的化学物质。 这项研究正在进行，因为目前没有有效的治疗这种类型的癌症。 我们还想取一片受试者的肿瘤和一些血液样本，并将其送到银行进行未来研究。 方法：受试者将在门诊接受6次访视。 每次访视时，他们将通过IV接受CNTO 328。 每次访问将持续约3-4小时。 在第7周，他们将通过X线、CT/MRI扫描和/或骨扫描进行PSA检测和疾病评估。 这次访问将持续约6-7小时。 在3个月结束时，将重新评估受试者的疾病。 如果他们的疾病稳定或对治疗有反应，他们可以接受另外6个周期，总共6个月的治疗，由研究医生决定。 临床意义：激素难治性前列腺癌患者的治疗。

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. OBJECTIVE: The primary objective of this study is to assess the confirmed PSA response in patients with hormone refractory D2 prostate cancer treated with CNTO 328. Secondary objectives of this study include the following: a. To assess overall survival and progression-free survival in this group of patients. b. To assess the objective response rate (confirmed and unconfirmed complete and partial response) among those patients with measurable disease. c. To evaluate the qualitative and quantitative toxicities of this regimen. d. To investigate in a preliminary manner the association of clinical study outcomes with potential markers of anti-IL6 activity. e. To investigate in a preliminary manner the association of clinical study outcomes with longitudinal measurements of C-reactive Protein. RESEARCH PLAN: The purpose of this study is to find out what effects (good and bad) the new drug CNTO 328 has on prostate cancer. CNTO 328 is a new anti-cancer drug that can block interleukin-6 (IL-6), a chemical in the blood that helps cancer cells grow. This research is being done because currently there is no effective treatment for this type of cancer. We would also like to take a piece of the subject's tumor, and some of their blood samples, and send them to a bank for future studies. METHODS: Subjects will be treated in the outpatient clinic for six visits. At each visit they will receive CNTO 328 by IV. Each visit will last about 3-4 hours. On week 7, they will have a PSA test and disease assessment by x-ray, CT/MRI scan and/or Bone Scan. This visit will last about 6-7 hours. At the end of 3 months, the subject's disease will be reassessed. If their disease is stable or is responding to treatment, they may receive another six cycles, a total of 6 months of treatment, as decided by the study doctor. CLINICAL RELEVANCE: Treatment for patients with hormone refractory prostate cancer.