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Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00041652
First Posted: July 15, 2002
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Immunomedics, Inc.
  Purpose
The purpose of this trial is to determine the safety of hMN14 at different dose levels in the treatment of either colorectal or breast cancer.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas

Resource links provided by NLM:


Further study details as provided by Immunomedics, Inc.:

Estimated Enrollment: 30
Study Start Date: February 2000
Estimated Study Completion Date: June 2003
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Disease Characteristics:

  • Histologic or cytologic diagnosis or either, colonic, rectal, or breast carcinoma
  • Measurable lesion diagnosed by CT scan
  • Recurrent/metastatic disease considered surgically unresectable.

Prior/Concurrent Therapy:

  • Chemotherapy: Patients who either have failed at least one regimen of standard systemic therapy, or are clinically asymptomatic and are not presently being considered for chemotherapy (Enrollment must occur at least 4 weeks beyond last treatment)
  • Other: Prior treatment with investigational agents is excluded unless follow-up is completed and patient is off study

Patient Characteristics/Inclusion Criteria:

  • Performance Status: Patients with a Karnofsky performance status > 70% (or equivalent, ECOG 0-1) and expected survival of at least 3 months.
  • Hematopoietic: WBC >/= 3000 mm3, neutrophils >/= 1500 mm3, platelets >/= 75,000, CEA < 300 ng/mL
  • Hepatic: Serum bilirubin </= 2.0 mg/dL, ALT < 2.5 x IULN
  • Cardiovascular: Patients with LVEF >/= 40% by required MUGA/2D-ECHO study.
  • Pulmonary: Patients with FEV1 >/= 60% by required Pulmonary Function Tests
  • Other: Patients agreeing to use a medically effective method of contraception during and for a period of 3 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. Patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041652


Locations
United States, California
Hoag Cancer Center
Newport Beach, California, United States, 92658
Sponsors and Collaborators
Immunomedics, Inc.
Investigators
Study Director: Terence Rugg, MD Immunomedics, Inc.
Study Chair: Lauri Welles, MD Immunomedics, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00041652     History of Changes
Other Study ID Numbers: IM-T-hMN14-04
First Submitted: July 11, 2002
First Posted: July 15, 2002
Last Update Posted: December 9, 2005
Last Verified: October 2005

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

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