Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041652
• Other study ID #: IM-T-hMN14-04
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2000
• Est. completion date: June 2003

Study information

• Verified date: October 2005
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma
• Colon Cancer
• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasms
• Neoplasms
• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• hMN14 (labetuzumab)

Locations

Country	Name	City	State
United States	Hoag Cancer Center	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States,