High-Dose Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
NCT ID: NCT00003392
Last Updated: 2012-02-22
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
PHASE2
61 participants
INTERVENTIONAL
1997-09-30
2003-01-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of high-dose chemotherapy and peripheral stem cell transplantation in treating patients with recurrent or refractory metastatic breast cancer.
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Detailed Description
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OUTLINE: This is a multicenter study. Patients receive mobilization therapy consisting of cyclophosphamide IV over 1 hour followed by paclitaxel IV over 3 hours, then filgrastim (G-CSF) beginning 24 hours following completion of paclitaxel and continuing through the last day of leukapheresis. Leukapheresis continues until an adequate number of CD34+ cells is collected. Following cell count recovery, patients receive 3 courses of high-dose chemotherapy: 2 courses of paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour, with the first course generally within 21 days after completion of leukapheresis and the second course 21-35 days after the first; then 1 course of melphalan IV infused over 30 minutes 21-35 days after the previous carboplatin dose. Each course of chemotherapy is followed 24-48 hours later by the infusion of G-CSF-mobilized peripheral blood progenitor cells and G-CSF. Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 96 evaluable patients will be accrued for this study over 3 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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filgrastim
10 mcg/kg/d, day 2 through last day of leukapheresis
carboplatin
18 AUC IV, approximately days 21, 42
cyclophosphamide
4 gm/m2 IV, day 1
melphalan
140 mg/m2 IV , approximately day 63
paclitaxel
170 mg/m2 IV day 1
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 to 65 Sex: Not specified Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 90,000/mm3 No prior inability to mobilize adequate peripheral blood progenitor cells for high dose therapy Hepatic: Bilirubin no greater than 1.8 mg/dL Transaminases stable and no greater than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF within normal limits No significant cardiovascular disease No coronary artery disease No arrhythmias No congestive heart failure Other: Not pregnant or nursing Negative pregnancy test required of fertile women Effective contraception required of fertile patients Not HIV positive No nonmalignant disease precluding protocol treatment No sensitivity to E. coli-derived drug preparations No prior participation in this study No greater than grade I neurotoxicity
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior cellular support for high dose chemotherapy Chemotherapy: See Disease Characteristics No more than 6 prior courses of chemotherapy for metastatic disease At least 3 weeks since prior chemotherapy and recovered No prior high dose chemotherapy with cellular support Endocrine therapy: No concurrent steroid therapy Concurrent hormonal therapy allowed Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior extensive pelvic radiation Surgery: Not specified Other: Recovered from acute toxic effects of any prior therapy No concurrent anticoagulation therapy
18 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Thomas C. Shea, MD
Role: STUDY_CHAIR
UNC Lineberger Comprehensive Cancer Center
Locations
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Scripps Clinic
La Jolla, California, United States
University of California San Diego
La Jolla, California, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Bone Marrow Stem Cell Transplant Institute of Florida
Fort Lauderdale, Florida, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Stem Cell Sciences
New York, New York, United States
University of Rochester School of Medicine
Rochester, New York, United States
New York Medical College
Valhalla, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Temple University Cancer Center
Philadelphia, Pennsylvania, United States
Methodist Hospital-Central Unit
Memphis, Tennessee, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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UNC-LCCC-970135
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-G98-1446
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
LCCC 9727
Identifier Type: -
Identifier Source: org_study_id
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