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High-Dose Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003392
Recruitment Status : Completed
First Posted : July 22, 2004
Last Update Posted : February 22, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: melphalan Drug: paclitaxel Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multiple Cycles of High Dose Chemotherapy Supported With Filgrastim and Peripheral Blood Progenitor Cells in Patients With Metastatic Breast Cancer
Study Start Date : September 1997
Actual Primary Completion Date : August 2002
Actual Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Biological: filgrastim
    10 mcg/kg/d, day 2 through last day of leukapheresis
  • Drug: carboplatin
    18 AUC IV, approximately days 21, 42
  • Drug: cyclophosphamide
    4 gm/m2 IV, day 1
  • Drug: melphalan
    140 mg/m2 IV , approximately day 63
  • Drug: paclitaxel
    170 mg/m2 IV day 1
  • Procedure: bone marrow ablation with stem cell support
  • Procedure: peripheral blood stem cell transplantation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory, metastatic breast cancer Patients previously treated for metastatic disease must show response to last standard dose chemotherapy regimen within 60 days of study entry OR Patients with no evidence of disease (e.g., resected skin lesions) must show no evidence of progression or bone disease No CNS metastases No disease progression following prior platinum or paclitaxel based regimens Hormone receptor status: Not specified

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003392

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United States, California
Scripps Clinic
La Jolla, California, United States, 92037
University of California San Diego
La Jolla, California, United States, 92093
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
Bone Marrow Stem Cell Transplant Institute of Florida
Fort Lauderdale, Florida, United States, 33313
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
United States, New York
Stem Cell Sciences
New York, New York, United States, 10016
University of Rochester School of Medicine
Rochester, New York, United States, 14642
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Temple University Cancer Center
Philadelphia, Pennsylvania, United States, 19140
United States, Tennessee
Methodist Hospital-Central Unit
Memphis, Tennessee, United States, 38104
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
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Study Chair: Thomas C. Shea, MD UNC Lineberger Comprehensive Cancer Center

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Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT00003392     History of Changes
Other Study ID Numbers: LCCC 9727
UNC-LCCC-970135 ( Other Identifier: UNC IRB )
NCI-G98-1446 ( Other Grant/Funding Number: NCI )
First Posted: July 22, 2004    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
stage IV breast cancer
recurrent breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Adjuvants, Immunologic