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

点击翻译按钮获取中文摘要

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.