A Phase I/II Study of Radioimmunotherapy With 90Y-Humanized MN-14 IgG Administered as a Single Dose to Patients With Refractory Metastatic/Recurrent Colorectal Carcinomas

Gilead Sciences19 个研究点分布在 5 个国家目标入组 72 人开始时间: 2000年1月最近更新: 2021年8月19日

适应症

试验速览

The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of colorectal cancer.

•Age Range: Male or Female at least 18 years of age
•Performance Status: Patients with a Karnofsky performance status > 70% (or equivalent, ECOG 0-1) and expected survival of at least 3 months.
•Hematopoietic: Hemoglobin > 10 g/dL; WBC > 3000 per mm3; Granulocyte count > 1,500 per mm3; Platelet count > 100,000 per mm3
•Hepatic: Total bilirubin < 1.5 times the institutional upper limit of normal (IULN)AST or ALT < 2 x IULN
•Renal: Creatinine < IULN
•Cardiovascular: Patients with LVEF >/= 50% by required MUGA/2D-ECHO study.
•Pulmonary: Patients with DFCO and FEV1 >/= 60% by required Pulmonary Function Tests.
•Other: Patients who have had a prior imaging study with a murine monoclonal antibody may be included. Patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.

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