NCT00003920

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine may prevent this from happening. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus cyclosporine and peripheral stem cell transplantation in treating patients who have metastatic breast cancer that has not responded to previous therapy.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1 breast-cancer

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

April 1, 1996

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

June 17, 2004

Completed
Last Updated

August 7, 2013

Status Verified

November 1, 2000

First QC Date

November 1, 1999

Last Update Submit

August 6, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

filgrastimBIOLOGICAL
cyclosporineDRUG
peripheral blood stem cell transplantationPROCEDURE
indium In 111 monoclonal antibody m170RADIATION
yttrium Y 90 monoclonal antibody m170RADIATION

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: Histologically confirmed refractory metastatic breast cancer Must have either relapsed or failed to achieve complete remission after combination chemotherapy with or without stem cell or marrow transplantation No CNS disease No generalized or total mass liver involvement greater than 25% volume No pulmonary metastasis involving greater than 25% of lung volume Tumor markers and evidence of metastatic disease by physical exam or radiography required for patients with bone disease only Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 to physiologic age of 55 Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 2000/mm3 Platelet count at least 150,000/mm3 Arterial blood gases within normal limits for age and sex Hepatic: See Disease Characteristics Bilirubin no greater than 1.3 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: LVEF at least 50% by MUGA Pulmonary: FEV1 and FVC at least 65% of predicted Corrected diffusing capacity at least 60% Other: Adequate venous access Able to tolerate apheresis, filgrastim (G-CSF), and cyclosporine Human anti-mouse antibody (HAMA) negative No other primary malignant neoplasm except curatively treated basal cell carcinoma or surgically cured carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No concurrent chemotherapy At least 1 year since prior high dose intensive marrow toxic therapy requiring stem cells or bone marrow transplantation No pulmonary toxicity due to prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy No prior radiotherapy to greater than 25% of total skeleton Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FilgrastimCyclosporinePeripheral 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 FactorsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeMetals, HeavyElementsInorganic ChemicalsMetals

Study Officials

  • Sally DeNardo, MD

    University of California, Davis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 17, 2004

Study Start

April 1, 1996

Last Updated

August 7, 2013

Record last verified: 2000-11

Locations

US(1)