NCT00003086

Brief Summary

RATIONALE: Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of repeated use of high-dose chemotherapy plus bone marrow transplantation and samarium 153 in treating women who have stage IV breast cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Mar 1997

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 1997

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2001

Completed
3 years until next milestone

First Posted

Study publicly available on registry

February 9, 2004

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

3.9 years

First QC Date

November 1, 1999

Last Update Submit

July 10, 2020

Conditions

Breast Cancer

Keywords

stage IV breast cancer

Interventions

filgrastimBIOLOGICAL
CAF regimenDRUG
carboplatinDRUG
cisplatinDRUG
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
fluorouracilDRUG
ifosfamideDRUG
melphalanDRUG
paclitaxelDRUG
thiotepaDRUG
peripheral blood stem cell transplantationPROCEDURE
samarium Sm 153 lexidronam pentasodiumRADIATION

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven metastatic breast cancer Adequate peripheral blood stem cells harvested and stored PATIENT CHARACTERISTICS: Age: 21-65 Sex: Female Performance status: 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL SGOT and SGPT normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Ejection fraction of at least 50% No symptomatic coronary artery disease Pulmonary: FEV1 and DLCO greater than 50% of predicted Other: Not pregnant Not HIV positive Not hepatitis B surface antigen positive No uncontrolled infection No other prior malignancy within 5 years except: Curatively treated in situ adenocarcinoma of the cervix Curatively treated nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Recovered from toxic effects of prior therapy Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease Prior adjuvant chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for metastatic disease 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)

Louisiana State University School of Medicine

Shreveport, Louisiana, 71130-3932, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FilgrastimCAF protocolCarboplatinCisplatinCyclophosphamideDoxorubicinFluorouracilIfosfamideMelphalanPaclitaxelThiotepaPeripheral Blood Stem Cell Transplantationsamarium Sm-153 lexidronam

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 FactorsCoordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazinesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesTriethylenephosphoramideAziridinesAzirinesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Benjamin B. Weinberger, MD

    Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

February 9, 2004

Study Start

March 1, 1997

Primary Completion

January 28, 2001

Study Completion

January 28, 2001

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

US(1)