Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer

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. Identifier: NCT00041652
Recruitment Status : Completed
First Posted : July 15, 2002
Last Update Posted : October 24, 2005
Information provided by:
Immunomedics, Inc.

July 11, 2002
July 15, 2002
October 24, 2005
February 2000
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00041652 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas
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.
Not Provided
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer
  • Colorectal Neoplasms
  • Colorectal Carcinoma
  • Breast Cancer
  • Breast Neoplasms
Drug: hMN14 (labetuzumab)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2003
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Not Provided
Immunomedics, Inc.
Not Provided
Study Director: Terence Rugg, MD Immunomedics, Inc.
Study Chair: Lauri Welles, MD Immunomedics, Inc.
Immunomedics, Inc.
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP