NCT00007891

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 or bone marrow transplantation may be able to replace immune cells that were destroyed by monoclonal antibody therapy used to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 1997

Longer than P75 for phase_1 breast-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1997

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

May 15, 2013

Status Verified

September 1, 2004

First QC Date

January 6, 2001

Last Update Submit

May 14, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancermale breast cancer

Interventions

filgrastimBIOLOGICAL
autologous bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
indium In 111 monoclonal antibody BrE-3RADIATION
yttrium Y 90 monoclonal antibody BrE-3RADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic breast cancer * BrE-3 positive * Relapsed or refractory disease with tumor progression after effective therapy allowed * Measurable or evaluable disease * Received at least one prior chemotherapy regimen for metastatic disease and have at least one of the following: * Chemotherapy refractory liver metastases more than 2 cm * Multiple non-resectable liver metastases * Brain metastases * Prior high-dose chemotherapy * Relapse within prior radiotherapy field * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * Over 18 Sex: * Male or female Menopausal status: * Not specified Performance status: * 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,000/mm3 * Absolute neutrophil count greater than 1,000/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin less than 2 times normal * SGOT/SGPT less than 2 times normal Renal: * Creatinine clearance greater than 60 mL/min Cardiovascular: * LVEF greater than 45% by MUGA scan Pulmonary: * DLCO and FEV 1.0 greater than 60% predicted Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No known hypersensitivity to E. coli derived proteins * No other comorbid condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior high-dose chemotherapy with autologous peripheral blood stem cell transplantation Chemotherapy: * See Disease Characteristics * See Biologic therapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * Not specified Other: * Recovered from prior therapy

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

Sponsors & Collaborators

Study Sites (2)

Cancer Research Institute of Contra Costa

San Francisco, California, 94107, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

FilgrastimPeripheral Blood Stem Cell TransplantationIndium

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, OperativeMetals, HeavyElementsInorganic ChemicalsMetals

Study Officials

  • Roberto L. Ceriani, MD, PhD

    Cancer Research Institute of Contra Costa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

June 1, 1997

Study Completion

October 1, 2004

Last Updated

May 15, 2013

Record last verified: 2004-09

Locations

US(2)