NCT00003877

Brief Summary

RATIONALE: Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. It is not yet known whether Stromagen improves the success of stem cell transplantation in women with breast cancer. PURPOSE: Randomized phase I/II trial to study the effectiveness of Stromagen during stem cell transplantation following chemotherapy in treating women with metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Sep 1998

Shorter than 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2000

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2000

Completed
3.6 years until next milestone

First Posted

Study publicly available on registry

July 16, 2004

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

1.4 years

First QC Date

November 1, 1999

Last Update Submit

March 3, 2011

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

filgrastimBIOLOGICAL
carboplatinDRUG
cyclophosphamideDRUG
paclitaxelDRUG
thiotepaDRUG
in vitro-treated bone marrow transplantationPROCEDURE
in vitro-treated peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: Histologically proven metastatic breast cancer involving at least 1 bone site Completed induction chemotherapy No active CNS disease Hormone receptor status: Estrogen receptor and progesterone receptor negative OR Hormone refractory disease PATIENT CHARACTERISTICS: Age: 18 to 64 Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC greater than 1000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Hepatitis B surface antigen negative Hepatitis C negative No cirrhosis Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: Cardiac ejection fraction greater than 50% by MUGA Pulmonary: DLCO greater than 50% Other: Not pregnant Fertile patients must use effective contraception No active infection No active alcohol or substance abuse within 6 months At least 1 year since clinically significant CNS disease or seizures HIV negative No other medical condition that would preclude evaluation of the patient PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: At least 3 years since prior radiotherapy, except local adjuvant therapy 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 (3)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FilgrastimCarboplatinCyclophosphamidePaclitaxelThiotepa

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 ChemicalsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenesTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Philip L. McCarthy, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 16, 2004

Study Start

September 1, 1998

Primary Completion

February 1, 2000

Study Completion

December 1, 2000

Last Updated

March 7, 2011

Record last verified: 2011-03

Locations

US(3)