High-Dose Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00003392
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
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.
- Detailed Description
OBJECTIVES: I. Determine the effects on 2 year progression-free survival of a regimen consisting of cyclophosphamide, paclitaxel, and filgrastim (G-CSF) to mobilize peripheral blood progenitor cells (PBPCs), followed by 2 courses of carboplatin and paclitaxel followed by 1 course of melphalan, each supported with PBPCs and G-CSF, in patients with recurrent or refractory, advanced breast cancer. II. Evaluate the feasibility of administering multiple courses of high dose chemotherapy in an outpatient setting for these patients. III. Evaluate the rate of complete response to the high dose therapy in these patients.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Scripps Clinic
🇺🇸La Jolla, California, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, 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
Scroll for more (4 remaining)Scripps Clinic🇺🇸La Jolla, California, United States