Safety Study of 90Y-hMN14 to Treat Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT00040599
First received: July 1, 2002
Last updated: January 8, 2008
Last verified: January 2008
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
Colon Cancer
Rectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Colorectal Tumor
Drug: hMN14 (labetuzumab)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Immunomedics, Inc.:

Estimated Enrollment: 72
Study Start Date: January 2000
Estimated Study Completion Date: January 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040599

Locations
United States, California
Hoag Cancer Center
Newport Beach, California, United States, 92658
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Bay Pines VA Medical Center
St. Petersburg, Florida, United States, 33744
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101-2799
Germany
Zentralklinik Bad Berka
Bad Berka, Germany, D99437
University Hospital Dresden
Dresden, Germany, D-01307
Hungary
University of Szeged Medical Center
Szeged, Hungary
Sweden
Uppsala University Hospital
Uppsala, Sweden, S-75185
Switzerland
Centre Pluridisciplinaire d'Oncologie
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
Immunomedics, Inc.
Investigators
Study Chair: William Wegener, MD Immunomedics, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00040599     History of Changes
Other Study ID Numbers: IM-T-hMN14-02
Study First Received: July 1, 2002
Last Updated: January 8, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Immunomedics, Inc.:
Colon Cancer
Rectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Colorectal Tumor

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Carcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 01, 2014