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 Sciences10 sites in 4 countries75 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 pancreatic cancer.

Registry

clinicaltrials.gov

Start Date

January 2000

End Date

December 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 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.