Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT00041652
First received: July 11, 2002
Last updated: October 21, 2005
Last verified: October 2005
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00041652     History of Changes
Other Study ID Numbers: IM-T-hMN14-04
Study First Received: July 11, 2002
Last Updated: October 21, 2005
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014