5 FU & Y 90 IN CEA PRODUCING COLORECTAL CANCER

5氟尿嘧啶

• 批准号: 6263722
• 负责人: JEFFREY Y WONG
• 金额: $ 3.56万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263722
• 关键词: adult human (21+); antitumor antibody; carcinoembryonal antigen; chimeric proteins; clinical research; clinical trial phase I; colorectal neoplasms; combination cancer therapy; fluorouracil; human subject; human therapy evaluation; immunoconjugates; injection /infusion; neoplasm /cancer immunotherapy; neoplasm /cancer radiation therapy; pharmacokinetics; yttrium

This trial will determine the maximum tolerated dose, the associated toxicities and evaluate the feasibility of delivering intraperitoneally administered Y-90 chimeric T84.66 for patients with abdominal carcinomatosis. This trial will also evaluate radiation dosimetry, antibody biodistribution and clearance and will begin to evaluate its anti-tumor effects. Physician Eligibility Summary: Histological diagnosis of cancer with CEA (Carcinoembryonic Antigen) producing tumors; Cancer of which the majority is confined to the peritoneal cavity and unresponsive to previous conventional treatment; Must have measurable or evaluable disease; No prior chemotherapy with Mitomycin-C or Nitrosureas; No prior abdomen or pelvic radiation therapy or radiation therapy to greater than 50% of bone marrow; Patients with greater than 25% liver involvement are ineligible; Prior immunotherapy or chemotherapy allowed; Age greater than or equal to 18 years; Must meet or exceed a Karnofsky Performance Status of 60% (Patient requires occasional assistance but is able to care for most of their own needs).

该试验将确定最大耐受剂量、相关毒性，并评估腹腔注射Y-90嵌合T84.66治疗腹部癌患者的可行性。该试验还将评估辐射剂量学、抗体生物分布和清除率，并将开始评估其抗肿瘤作用。医师资格总结：组织学诊断为CEA（癌胚抗原）产生肿瘤的患者；大多数局限于腹膜腔的癌症，对以往的常规治疗无反应；必须有可测量或可评估的疾病；既往未使用丝裂霉素c或亚硝基脲进行化疗；既往未接受过腹部或盆腔放射治疗或超过50%的骨髓放射治疗；肝脏受累超过25%的患者不符合资格；允许既往免疫治疗或化疗；年龄大于或等于18岁；必须达到或超过Karnofsky性能状态的60%（患者需要偶尔的帮助，但能够照顾自己的大部分需求）。