NCT00020410

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of monoclonal antibody therapy and kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody followed by peripheral stem cell transplantation in treating patients who have relapsed or metastatic breast cancer.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
completed

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

February 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

April 30, 2015

Status Verified

September 1, 2003

First QC Date

July 11, 2001

Last Update Submit

April 29, 2015

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancermale breast cancer

Interventions

filgrastimBIOLOGICAL
peripheral blood stem cell transplantationPROCEDURE
yttrium Y 90 monoclonal antibody B3RADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage IV breast cancer * At least 1 site of relapse or metastatic disease * Progressive disease after at least 1 prior chemotherapy regimen for metastatic disease * One regimen must contain an anthracycline and a taxane as adjuvant therapy or for metastatic disease * Prior adjuvant chemotherapy allowed * Measurable or evaluable disease * Tumor tissue must express B3 antigen on the surface of more than 30% of tumor cells * No CNS metastasis * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Male or female Menopausal status: * Not specified Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count greater than 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin normal * SGOT and SGPT no greater than 2 times upper limit of normal * PT normal * Hepatitis B surface antigen negative * Hepatitis C negative Renal: * Creatinine no greater than 1.4 mg/dL Cardiovascular: * Ejection fraction at least 45% by MUGA or echocardiogram Pulmonary: * FEV\_1 greater than 60% of predicted * FVC at least 55% of predicted * DLCO at least 55% of predicted Other: * No known seizure disorders * No history of autoimmune disease * No other active malignancy except previously treated basal cell skin cancer * No other concurrent medical or psychiatric condition that would preclude study participation * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Chemotherapy * No prior mouse antibody Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered * No prior high-dose chemotherapy with bone marrow or stem cell transplantation Endocrine therapy: * At least 4 weeks since prior hormonal therapy * No concurrent chronic steroids Radiotherapy: * At least 4 weeks since prior local radiotherapy to one site and recovered * No prior radiotherapy to the pelvis and/or spine Surgery: * Not specified Other: * No concurrent anticoagulants

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

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

FilgrastimPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Claude Sportes, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

February 1, 2001

Last Updated

April 30, 2015

Record last verified: 2003-09

Locations

US(2)