Safety Study of 90Y-hMN14 to Treat Colorectal Cancer

NCT00040599 | Completed Phase 1

• 1 other identifier: IM-T-hMN14-02
• Study Type: interventional
• Target: 72
• Locations: 5 countries
• Sites: 10

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.

Conditions

Colorectal Cancer; Colon Cancer; Rectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Colorectal Tumor

Keywords

Colon Cancer; Rectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Colorectal Tumor

Interventions

hMN14 (labetuzumab) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (10)

Hoag Cancer Center

Newport Beach, California, 92658, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Bay Pines VA Medical Center

St. Petersburg, Florida, 33744, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101-2799, United States

Location

Zentralklinik Bad Berka

Bad Berka, D99437, Germany

Location

University Hospital Dresden

Dresden, D-01307, Germany

Location

University of Szeged Medical Center

Szeged, Hungary

Location

Uppsala University Hospital

Uppsala, S-75185, Sweden

Location

Centre Pluridisciplinaire d'Oncologie

Lausanne, CH-1011, Switzerland

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

labetuzumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• William Wegener, MD

  Gilead Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 1, 2002
• First Posted: July 3, 2002
• Study Start: January 1, 2000
• Study Completion: January 1, 2004
• Last Updated: August 19, 2021

Record last verified: 2008-01

Locations

US (5); HU (1); DE (2); SE (1); CH (1)