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Chemotherapy, Filgrastim, and Stem Cell Transplantation With Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer

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ClinicalTrials.gov Identifier: NCT00004172
Recruitment Status : Completed
First Posted : September 16, 2004
Last Update Posted : June 12, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Tracking Information
First Submitted Date  ICMJE December 10, 1999
First Posted Date  ICMJE September 16, 2004
Last Update Posted Date June 12, 2012
Study Start Date  ICMJE October 1999
Actual Primary Completion Date October 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy, Filgrastim, and Stem Cell Transplantation With Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer
Official Title  ICMJE Peripheral Stem Cell Transplantation Protocol for Patients With Previously Treated Advanced Breast Cancer - A Phase II Pilot Study
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase II trial to compare the effectiveness of two regimens of chemotherapy and filgrastim plus stem cell transplantation in treating patients who have previously untreated stage III or stage IV breast cancer.

Detailed Description

OBJECTIVES: I. Assess the antitumor response, survival, and disease free survival following high dose carboplatin, ifosfamide, and thiotepa with autologous peripheral blood stem cell (PBSC) support and consolidation radiotherapy to sites of pretreatment bulk disease in patients with previously treated advanced breast cancer. II. Assess the toxicity of high dose chemotherapy in these patients. III. Compare the effectiveness of PBSC mobilization with high dose cyclophosphamide and filgrastim (G-CSF) vs G-CSF alone in this patient population.

OUTLINE: Patients are assigned to 1 of 2 peripheral blood stem cell (PBSC) mobilization groups at the discretion of the attending physician: Group 1: Patients receive high dose cyclophosphamide IV over 6 hours and filgrastim (G-CSF) subcutaneously (SQ) daily beginning 24 hours after completion of cyclophosphamide and continuing until 3 days after blood counts have recovered and until PBSC are harvested. Group 2: Patients receive G-CSF SQ daily alone until PBSC are harvested. Both groups: PBSC are harvested on days 15-19 after cyclophosphamide infusion or when blood counts recover. Patients receive high dose carboplatin IV continuously, ifosfamide IV over 4 hours, and thiotepa IV over 1 hour on days -5 to -3. PBSC are reinfused beginning 48 hours after completion of combination chemotherapy. Patients receive G-CSF SQ beginning on day 0 and continuing until 3 days after blood counts have recovered. Sites of pretransplantation metastases greater than 3 cm are irradiated beginning after transplantation and after blood counts recover. Patients are followed every month for 1 year.

PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Biological: filgrastim
  • Drug: carboplatin
  • Drug: cyclophosphamide
  • Drug: ifosfamide
  • Drug: thiotepa
  • Procedure: peripheral blood stem cell transplantation
  • Radiation: radiation therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2003
Actual Primary Completion Date October 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS: Histologically proven previously treated stage III or IV breast cancer No CNS disease Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Physiologic 65 and under Menopausal status: Not specified Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Hepatic function normal unless due to liver metastases Bilirubin less than 1.5 times normal SGOT or SGPT less than 1.5 times normal Alkaline phosphatase less than 1.5 times normal If hepatitis C antibody positive, then liver function must be normal OR liver dysfunction must be due to metastatic disease and not chronic hepatitis Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF normal No myocardial infarction within past 6 months No significant arrhythmia requiring medications No history of congestive heart failure Pulmonary: DLCO at least 50% predicted FEV1 and/or FVC at least 75% predicted No serious nonneoplastic pulmonary disease (severe chronic obstructive lung disease) that would preclude study therapy Other: Not pregnant Negative pregnancy test HIV negative Hepatitis B and C surface antigen negative No active serious medical condition that would preclude study therapy

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004172
Other Study ID Numbers  ICMJE NU 92B3T
NU-92B3T
NCI-G99-1640
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Jane N. Winter, MD Robert H. Lurie Cancer Center
PRS Account Northwestern University
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP