NCT00004085

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radioimmunotherapy used to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy plus peripheral stem cell transplantation in treating patients who have stage IV breast cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1 breast-cancer

Geographic Reach
1 country

3 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

May 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2002

Completed
2 years until next milestone

First Posted

Study publicly available on registry

April 15, 2004

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2011

Enrollment Period

4 years

First QC Date

December 10, 1999

Last Update Submit

June 21, 2011

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Outcome Measures

Primary Outcomes (1)

  • Safety

    maximum tolerated dose

    12 weeks

Interventions

filgrastimBIOLOGICAL

as prescribed by physician

autologous bone marrow transplantationPROCEDURE

1-2 weeks prior to treatment

peripheral blood stem cell transplantationPROCEDURE

1-2 weeks prior to treatment

yttrium Y 90 monoclonal antibody MN-14RADIATION

intravenous infusion over 30 min, single dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage IV breast cancer Measurable disease after firstline or greater chemotherapy Evidence of CEA expression by: Serum CEA at least 10 ng/mL OR Positive immunostaining of primary or metastatic tumors with a CEA-specific antibody Positive imaging of at least 1 confirmed tumor by pre-therapy indium In 111 monoclonal antibody MN-14 No brain metastases Bone marrow biopsy prior to stem cell mobilization required to assess cellularity and tumor involvement Cellularity greater than 60% of normal Tumor involvement less than 25% Chromosome analysis of bone marrow aspirate (optional) No brain metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Not specified Menopausal status: Not specified Performance status: Karnofsky 70-100% OR ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 mg/dL AST less than 2 times upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN Cardiovascular: Cardiac ejection fraction greater than 50% by MUGA Pulmonary: DLCO greater than 70% of predicted FVC and FEV1 greater than 70% of predicted Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No severe anorexia, nausea or vomiting, or urinary incontinence No other significant concurrent medical problem including severe psychiatric, epileptic, or diabetic disease No prisoners If received prior chimeric or humanized antibody (e.g., trastuzumab (Herceptin)), must not have allergy to yttrium Y 90 monoclonal antibody MN-14 PRIOR CONCURRENT THERAPY: Biologic therapy: No prior peripheral blood stem cell rescue Chemotherapy: See Disease Characteristics At least 1 course of prior chemotherapy At least 4 weeks since prior chemotherapy No prior high-dose chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to more than 30% of red bone marrow Surgery: At least 4 weeks since prior major surgery

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

Sponsors & Collaborators

Study Sites (3)

Garden State Cancer Center

Belleville, New Jersey, 07103, United States

Location

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

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

  • Jack D. Burton, MD

    Garden State Cancer Center at the Center for Molecular Medicine and Immunology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

April 15, 2004

Study Start

May 1, 1998

Primary Completion

May 1, 2002

Last Updated

June 22, 2011

Record last verified: 2011-06

Locations

US(3)