Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer - Full Text View

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 I Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer Colorectal Cancer

ChemIDplus related topics:

Labetuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study

Official Title:	A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas

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

Study ID Numbers:	IM-T-hMN14-04
First Received:	July 11, 2002
Last Updated:	October 21, 2005
ClinicalTrials.gov Identifier:	NCT00041652
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

Study placed in the following topic categories:

Digestive System Neoplasms

Skin Diseases

Gastrointestinal Diseases

Rectal Neoplasms

Colonic Diseases

Breast Neoplasms

Intestinal Diseases

Rectal Diseases

Recurrence

Intestinal Neoplasms

Rectal neoplasm

Carcinoma

Digestive System Diseases

Gastrointestinal Neoplasms

Rectal cancer

Colonic Neoplasms

Colorectal Neoplasms

Breast Diseases

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Immunomedics, Inc.
Information provided by:	Immunomedics, Inc.
ClinicalTrials.gov Identifier:	NCT00041652