Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer

Phase 1

Completed

• Conditions: Pancreatic Neoplasms

• Registration Number: NCT00041639
• Lead Sponsor: Gilead Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2002-07-11
• Study First Submitted QC: 2002-07-12
• Study First Posted: 2002-07-15
• Study Completion: 2003-12
• Status Verified: 2004-01
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (10)

University of Pittsburgh Cancer Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Hoag Cancer Center; 🇺🇸 Newport Beach, California, United States

Medizinische Fakultaet der Charité Berlin; 🇩🇪 Berlin, Germany

Bay Pines VA Medical Center; 🇺🇸 Saint Petersburg, Florida, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Universitaetsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Medical University of Szeged; 🇭🇺 Szeged, Hungary

Semmelweis University; 🇭🇺 Budapest, Hungary