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

Y 90 CHIMERIC T84 66 ANTI CEA ANTIBODY G CSF, STEM CELL SUPPORT IN BREAST CANCER
Y 90 嵌合 T84 66 抗 CEA 抗体 G CSF,对乳腺癌的干细胞支持
批准号:
6303642
负责人:
JEFFREY Y WONG
金额:
$3.56万
依托单位国家:
美国
项目类别:
财政年份:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-12-01 至 2000-11-30

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中文摘要
翻译
摘要:本试验的总体目的是评估放射标记抗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;开始评估其抗肿瘤作用,并确定干细胞和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)。医师资格概述:乳腺癌的组织学诊断;CEA(癌胚抗原)产生乳腺肿瘤;转移性疾病的证据(IV期);必须达到或超过Karnofsky绩效状态(70%)(患者能照顾自己,但无法进行正常活动或主动工作);年龄大于或等于18岁;既往放疗、免疫治疗或化疗在研究开始前4周完成;接受全骨盆放射治疗或超过40%骨髓放射治疗的患者不合格;脑受累或骨髓受累超过20%的患者不适合。
英文摘要
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.
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