Y 90 CHIMERIC T84 66 ANTI CEA ANTIBODY G CSF, STEM CELL SUPPORT IN BREAST CANCER

医师摘要：本试验的总体目的是评价放射性标记的抗CEA（癌胚抗原）抗体治疗的生物分布、肿瘤靶向特性和药代动力学;开始评价其抗肿瘤作用，并确定在干细胞和G-CSF（粒细胞集落刺激因子）支持下可给予的最高、最安全剂量（最大耐受剂量）。医师资格总结：乳腺癌的组织学诊断（癌胚抗原）生成性乳腺肿瘤;转移性疾病证据（第四阶段）;必须达到或超过70%的Karnofsky性能状态（患者能自理，但不能进行正常活动或从事积极工作）;年龄大于或等于18岁;入组研究前4周完成既往放疗、免疫治疗或化疗;接受全骨盆放疗或超过40%骨髓放疗的患者不合格;脑受累或骨髓受累超过20%的患者不合格。

Physician Abstract: The overall objectives of this trial are to evaluate the biodistribution, tumor targeting properties and pharmacokinetics of a radiolabeled anti-CEA (Carcinoembryonic Antigen) antibody for therapy; To begin to evaluate its anti-tumor effects and to determine the highest, safest dose (maximum tolerated dose) that can be administered with stem cell and G-CSF (Granulocyte Colony Stimulating Factor) support. Physician Eligibility Summary: Histologic diagnosis of breast cancer; CEA (Carcinoembryonic Antigen) producing breast tumor; Evidence of metastatic disease (Stage IV); Must meet or exceed a Karnofsky Performance Status of 70% (Patient cares for self, but is unable to carry on normal activity or to do active work); Age greater than or equal to 18 years; Prior radiation therapy, immunotherapy, or chemotherapy completed 4 weeks prior to study entry; Patients who received whole pelvis radiation therapy or radiation therapy to greater than 40% of bone marrow are ineligible; Patients with brain involvement or greater than 20% bone marrow involvement are ineligible.