A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas

Gilead Sciences1 site in 1 country30 target enrollmentFebruary 2000

Overview

The purpose of this trial is to determine the safety of hMN14 at different dose levels in the treatment of either colorectal or breast cancer.

Registry

clinicaltrials.gov

Start Date

February 2000

End Date

June 2003

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•Performance Status: Patients with a Karnofsky performance status \> 70% (or equivalent, ECOG 0-1) and expected survival of at least 3 months.
•Hematopoietic: WBC \>/= 3000 mm3, neutrophils \>/= 1500 mm3, platelets \>/= 75,000, CEA \< 300 ng/mL
•Hepatic: Serum bilirubin \</= 2.0 mg/dL, ALT \< 2.5 x IULN
•Cardiovascular: Patients with LVEF \>/= 40% by required MUGA/2D-ECHO study.
•Pulmonary: Patients with FEV1 \>/= 60% by required Pulmonary Function Tests
•Other: Patients agreeing to use a medically effective method of contraception during and for a period of 3 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. Patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.