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 Sciences10 sites in 5 countries72 target enrollmentJanuary 2000

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2000

End Date

January 2004

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•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.