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

Tracking Information

First Received Date ^ICMJE

July 11, 2002

Last Updated Date

October 21, 2005

Start Date ^ICMJE

February 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00041652 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study

Condition ^ICMJE

Colorectal Cancer
Colon Cancer
Rectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Breast Cancer
Breast Neoplasms

Intervention ^ICMJE

Drug: hMN14 (labetuzumab)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00041652

Responsible Party

Study ID Numbers ^ICMJE

IM-T-hMN14-04

Study Sponsor ^ICMJE

Immunomedics, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Terence Rugg, MD	Immunomedics, Inc.
Study Chair:	Lauri Welles, MD	Immunomedics, Inc.

Information Provided By

Immunomedics, Inc.

Verification Date

October 2005

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