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Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer

Primary Purpose

Colorectal Cancer, Colon Cancer, Rectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
hMN14 (labetuzumab)
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Breast Cancer, Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hoag Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2002
Last Updated
August 12, 2021
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00041652
Brief Title
Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
Official Title
A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Breast Cancer, Breast Neoplasms
Keywords
Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Breast Cancer, Breast Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
hMN14 (labetuzumab)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terence Rugg, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lauri Welles, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Hoag Cancer Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer

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