NCT00066547

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effect of monoclonal antibody therapy on the body and its effectiveness in treating women who have locally advanced or metastatic breast cancer that was previously treated with combination chemotherapy.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
Last Updated

December 4, 2013

Status Verified

August 1, 2004

First QC Date

August 6, 2003

Last Update Submit

December 3, 2013

Conditions

Breast Cancer

Keywords

recurrent breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Interventions

monoclonal antibody HuHMFG1BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed breast cancer * Locally advanced or metastatic disease * No inflammatory breast cancer * Polymorphic epithelial mucin (PEM) antigen overexpression by immunohistochemistry * Previously treated with an anthracycline and a taxane in any combination for breast cancer * No more than 2 prior chemotherapy regimens, including adjuvant /neoadjuvant therapy * No more than 1 prior regimen for distant metastatic disease * Any number of prior hormonal or biologic therapy regimens allowed * Measurable disease * At least one unidimensionally measurable lesion not previously irradiated * The following are not considered measurable lesions: * Bone * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Lymphangitis cutis/pulmonis * Abdominal masses not confirmed and followed by imaging techniques * Cystic lesions * No metastases accessible to complete surgical resection * No CNS metastasis by CT scan * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * WHO 0-2 Life expectancy * At least 4 months Hematopoietic * Hemoglobin at least 10 g/dL * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL * ALT and AST no greater than 2.5 times upper limit of normal (ULN) (less than 5 times ULN if liver metastases are present) Renal * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance greater than 60 mL/min * No hyperuricemia (uric acid at least 1.25 times ULN) * No hypercalcemia (calcium at least 11.5 mg/dL \[corrected for serum albumin\]) Cardiovascular * LVEF at least 45% by MUGA or echocardiogram within the past 4 weeks Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3-6 months after study participation * No other prior malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia * No other concurrent uncontrolled comorbid illness that represents unacceptable risk in the opinion of the investigator * No legal incapacity PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * More than 2 weeks since prior growth factors to aid hematologic recovery * No other concurrent immunotherapy Chemotherapy * See Disease Characteristics * More than 4 weeks since prior cytotoxic chemotherapy * No concurrent chemotherapy for metastatic breast cancer Endocrine therapy * See Disease Characteristics * No concurrent endocrine therapy for metastatic breast cancer * No concurrent chronic corticosteroid therapy * No concurrent high-dose corticosteroids Radiotherapy * More than 4 weeks since prior radiotherapy except for palliation * No concurrent antitumor radiotherapy except for palliation Surgery * More than 4 weeks since prior major surgery Other * More than 2 weeks since prior blood transfusions to aid hematologic recovery * No participation in any other investigational drug study * No other concurrent investigational drugs * No other concurrent antitumor therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

epitumomab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mark D. Pegram, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

May 1, 2003

Last Updated

December 4, 2013

Record last verified: 2004-08

Locations

US(1)