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
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: ifosfamide Drug: thiotepa Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 2|
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 :||Interventional (Clinical Trial)|
|Official Title:||Peripheral Stem Cell Transplantation Protocol for Patients With Previously Treated Advanced Breast Cancer - A Phase II Pilot Study|
|Study Start Date :||October 1999|
|Primary Completion Date :||October 2003|
|Study Completion Date :||October 2003|
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 ClinicalTrials.gov identifier (NCT number): NCT00004172
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611|
|Study Chair:||Jane N. Winter, MD||Robert H. Lurie Cancer Center|