BISPECIFIC ANTIBODY MDX H210 COMBINED W/ GM CSF IN PROSTATE CANCER

本研究的目的是描述一项在晚期激素难治性前列腺癌患者和可评估的转移性或局部晚期肾癌患者中进行的II期研究，研究MDX-H210的安全性、毒性和临床疗效。MDX-H210是一种识别HER2/neu和高亲和力Fc(Gamma)RI受体的双特异性抗体，与GM-CSF联合使用。患者将在研究的第4、11和18天接受15.0 mg/m^2的BsAb静脉滴注。根据主要研究人员的判断，双特异性抗体可以在住院或门诊使用。如果发生严重毒性，患者将被送往医院进行管理。将使用体检和实验室测试来监测患者的安全性和毒性。BsAb与肿瘤靶组织结合，并进行免疫学检测。在选定的患者中，单核细胞/中性粒细胞将被标记为TC-99，以测试它们在GM-CSF治疗后运输到肿瘤组织的能力。对于可测量疾病的患者，将对抗肿瘤反应进行初步评估。对于有可评估疾病(如骨转移)的患者，将通过放射学和血清学方法对疾病进行评估。将使用生活质量监测系统评估所有患者的症状益处。

The purpose of this study is to describe a Phase II study, in patients with advanced hormone refractory prostate cancer and evaluable patients with metastatic or locally advanced renal cell carcinoma, of the safety, toxicities, and clinical efficacy of MDX-H210, a bispecific antibody that recognizes HER2/neu and the high affinity Fc(gamma)RI receptor, in combination with GM-CSF. Patients will receive an intravenous infusion of BsAb at 15.0 mg/m^2 on study days 4,11, and 18. Bispecific antibody may be administered on either an in-patient or out-patient basis at the discretion of the principal investigatior. Patients will be admitted to the hospital to manage significant toxicity if it occurs. Physical examination and laboratory testing will be used to monitor patient safety and toxicity. BsAb binding to tumor target tissue, and immunologic assays will be performed. In selected patients, monocytes/neutropils will be labeled with Tc-99 to test their ability to traffic to tumor tissue after GM-CSF therapy. In patients with measurable disease, preliminary assessment will be made of anti-tumor responses. In patients with evaluable disease (e.g. bone metastasis), evaluation of the disease will be made by radiologic and serologic methods. All the patients will be assessed for symptomatic benefits using a quality of life monitoring system.