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

Gilead Sciences15 个研究点分布在 4 个国家目标入组 75 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 pancreatic cancer.

•Performance Status: Patients with a Karnofsky performance status > 70% (or equivalent, ECOG 0-1) and an expected survival rate of at least 3 months
•Hematopoietic: Hemoglobin > 10g/dL; WBC > 3000 per mm3; Granulocyte count > 1500 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 DF and FEV1 >/= 60 % by required Pulmonary Function Tests
•Gastrointestinal:Patients with severe anorexia or other related symptomology are excluded
•Central Nervous System: Patient with known metastatic disease to the CNS are excluded
•Other: Patients who have had a prior imaging study with a murine 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 preformed 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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