Safety Study of 90Y-hMN14 to Treat Colorectal Cancer

Phase 1

Completed

• Conditions: Colorectal Carcinoma; Colon Cancer; Rectal Cancer; Colorectal Neoplasms; Colorectal Cancer; Colorectal Tumor

• Registration Number: NCT00040599
• 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 colorectal cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2002-07-01
• Study First Submitted QC: 2002-07-02
• Study First Posted: 2002-07-03
• Study Completion: 2004-01
• Status Verified: 2008-01
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (10)

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

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

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

Centre Pluridisciplinaire d'Oncologie; 🇨🇭 Lausanne, Switzerland

University Hospital Dresden; 🇩🇪 Dresden, Germany

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

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

University of Szeged Medical Center; 🇭🇺 Szeged, Hungary

Zentralklinik Bad Berka; 🇩🇪 Bad Berka, Germany

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