Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004172
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
1999-12-10
Brief Title:
Chemotherapy Filgrastim and Stem Cell Transplantation With Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Peripheral Stem Cell Transplantation Protocol for Patients With Previously Treated Advanced Breast Cancer - A Phase II Pilot Study
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G99-1640 | None | None | None |
| NU-92B3T | None | None | None |