Peripheral Stem Cell Transplantation With or Without Stromagen Following Chemotherapy in Treating Women With Metastatic Breast Cancer
NCT ID: NCT00003877
Last Updated: 2011-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
1998-09-30
2000-12-31
Brief Summary
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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.
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Detailed Description
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OUTLINE: This is a randomized, placebo controlled, blinded study. Patients are randomly assigned to one of three treatment arms. All patients undergo mobilization of peripheral blood stem cells (PBSC) using cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1, and filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until completion of leukapheresis. PBSC and bone marrow cells are collected and CD34 positive cells are then selected. About 4 weeks later, patients receive high dose chemotherapy. Cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours are administered on days -7 to -4. Patients then receive placebo or one of two doses of expanded mesenchymal stem cells (Stromagen) IV on day -1 and CD34+ selected PBSC IV over 2 hours on day 0. Patients are followed at 6 weeks and 12 weeks, than at 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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filgrastim
carboplatin
cyclophosphamide
paclitaxel
thiotepa
in vitro-treated bone marrow transplantation
in vitro-treated peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
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
18 Years
64 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Roswell Park Cancer Institute
OTHER
Responsible Party
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Roswell Park Cancer Institute
Principal Investigators
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Philip L. McCarthy, MD
Role: STUDY_CHAIR
Roswell Park Cancer Institute
Locations
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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RPCI-DS-9828
Identifier Type: -
Identifier Source: secondary_id
CWRU-OSIR-1198
Identifier Type: -
Identifier Source: secondary_id
OSIRIS-101
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1516
Identifier Type: -
Identifier Source: secondary_id
CDR0000067043
Identifier Type: -
Identifier Source: org_study_id
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