Safety Study of 90Y-hMN14 to Treat Colorectal Cancer

A Phase I/II Study of Radioimmunotherapy With 90Y-Humanized MN-14 IgG Administered as a Single Dose to Patients With Refractory Metastatic/Recurrent Colorectal Carcinomas

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

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Colorectal Cancer; Rectal Cancer; Colon Cancer; Colorectal Carcinoma; Colorectal Tumor
• Intervention / Treatment: Drug: hMN14 (labetuzumab)

• Study Type: Interventional
• Enrollment: 72
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Bad Berka, Germany, D99437
    • Zentralklinik Bad Berka
  • Dresden, Germany, D-01307
    • University Hospital Dresden
• Hungary
  • Szeged, Hungary
    • University of Szeged Medical Center
• Sweden
  • Uppsala, Sweden, S-75185
    • Uppsala University Hospital
• Switzerland
  • Lausanne, Switzerland, CH-1011
    • Centre Pluridisciplinaire d'Oncologie
• United States
  • California
    • Newport Beach, California, United States, 92658
      • Hoag Cancer Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Saint Petersburg, Florida, United States, 33744
      • Bay Pines VA Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Cancer Institute
  • Washington
    • Seattle, Washington, United States, 98101-2799
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Disease Characteristics:

• Patients with a documented histologic or cytologic diagnosis of a colonic or rectal malignancy.
• Patients with recurrent, advanced and/or metastatic disease, who have either failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
• Patients with at least one identified (confirmed) and measurable tumor site* with no tumor site > 5 cm in the greatest dimension.

Prior/Concurrent Therapy:

• Surgery: Patients are excluded if they have had major surgery either during or within four weeks prior to study entry.
• Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority. Patients must have completed chemotherapeutic agents four weeks prior to study entry.
• Biologic Therapy: Patients who have received a chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant reactivity with hMN-14 IgG (i.e., HAHA).
• Radiotherapy: No prior radiotherapy within four weeks of study entry. No prior external beam irradiation to a field that includes more than 30% of the red marrow. No prior radiation to maximal tolerable levels for any critical organ (e.g., 3,000 cGy for the liver, and 2,000 cGy for the lungs and kidneys). Patients who have had standard pelvic field radiation as adjuvant therapy for rectal carcinoma will be eligible only after the MTD is established.
• Other: Any experimental therapy (i.e., drugs, biologicals, procedures) for the primary malignancy, either during or within four weeks prior to study entry.

Patient Characteristics/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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Chair: William Wegener, MD, Gilead Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Study Completion: January 1, 2004

Study Registration Dates

• First Submitted: July 1, 2002
• First Submitted That Met QC Criteria: July 2, 2002
• First Posted (Estimate): July 3, 2002

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Rectal Cancer; Colon Cancer; Colorectal Carcinoma; Colorectal Neoplasms; Colorectal Tumor
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Carcinoma; Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Labetuzumab
• Other Study ID Numbers: IM-T-hMN14-02