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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
History of Changes

July 11, 2002
October 21, 2005
February 2000
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Complete list of historical versions of study NCT00041652 on ClinicalTrials.gov Archive Site
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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
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer
  • Colorectal Neoplasms
  • Colorectal Carcinoma
  • Breast Cancer
  • Breast Neoplasms
Drug: hMN14 (labetuzumab)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2003
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00041652
IM-T-hMN14-04
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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