Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004174
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Advanced Breast Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
High Dose Paclitaxel Added to Cyclophosphamide and Thiotepa Followed by Autologous Stem Cell Rescue A Phase I Trial in Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-07
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 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 I trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have stage III or stage IV breast cancer
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have stage III or stage IV breast cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of paclitaxel when combined with high dose cyclophosphamide and thiotepa followed by autologous peripheral blood stem cell transplantation and radiotherapy in patients with advanced breast cancer II Assess the overall safety and toxicity of this regimen in these patients
OUTLINE This is a dose escalation study of paclitaxel Mobilization and harvest Patients undergo mobilization of peripheral blood stem cells PBSC according to the protocol currently used or patients may be mobilized using cytokines alone or chemomobilization at the discretion of the attending physician PBSC are harvested and selected for CD34 cells If an adequate number of CD34 cells are not harvested autologous bone marrow may be used Preparative regimen Patients receive paclitaxel IV over 24 hours on day -5 and high dose thiotepa IV over 2 hours and high dose cyclophosphamide IV over 2 hours on day -6 day -4 following paclitaxel infusion and day -2 Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose limiting toxicity Transplantation PBSC are reinfused on day 0 or a minimum of 48 hours after completion of chemotherapy Patients receive filgrastim G-CSF subcutaneously 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 PBSC transplantation and after blood counts recover Patients are followed every month for 1 year then every 3 months thereafter
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study within 1 year
OUTLINE This is a dose escalation study of paclitaxel Mobilization and harvest Patients undergo mobilization of peripheral blood stem cells PBSC according to the protocol currently used or patients may be mobilized using cytokines alone or chemomobilization at the discretion of the attending physician PBSC are harvested and selected for CD34 cells If an adequate number of CD34 cells are not harvested autologous bone marrow may be used Preparative regimen Patients receive paclitaxel IV over 24 hours on day -5 and high dose thiotepa IV over 2 hours and high dose cyclophosphamide IV over 2 hours on day -6 day -4 following paclitaxel infusion and day -2 Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose limiting toxicity Transplantation PBSC are reinfused on day 0 or a minimum of 48 hours after completion of chemotherapy Patients receive filgrastim G-CSF subcutaneously 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 PBSC transplantation and after blood counts recover Patients are followed every month for 1 year then every 3 months thereafter
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| NU-96B1 | None | None | None |
| NCI-G99-1641 | None | None | None |