Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002680
Status:
COMPLETED
Last Update Posted:
2013-07-24
First Post:
1999-11-01
Brief Title:
Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Phase II Trial of Sequential High-Dose Alkylating Agents in Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2009-08
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 kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of sequential high-dose chemotherapy followed by peripheral stem cell transplantation in treating patients with metastatic breast cancer that is responding to chemotherapy
PURPOSE Phase II trial to study the effectiveness of sequential high-dose chemotherapy followed by peripheral stem cell transplantation in treating patients with metastatic breast cancer that is responding to chemotherapy
Detailed Description:
OBJECTIVES I Determine the feasibility and efficacy of sequential high-dose cyclophosphamide melphalan and thiotepa plus autologous peripheral blood stem cell rescue in patients with metastatic breast cancer with ongoing objective response to prior induction chemotherapy
OUTLINE Patients receive sequential therapy beginning with regimen A Regimen A Patients receive cyclophosphamide IV over 1 hour every 6 hours or more for 4 doses within 36 hours Patients receive filgrastim G-CSF subcutaneously SC daily beginning 2 days after completion of cyclophosphamide and continuing until autologous peripheral blood stem cells PBSC are harvested Regimen B Beginning at least 3 weeks after initiation of regimen A patients receive melphalan IV on days 1 and 2 Beginning on day 4 a portion of the PBSC are reinfused Patients receive G-CSF SC daily beginning on day 4 and continuing until at least day 10 Regimen C Beginning at least 3 weeks after initiation of regimen B patients receive thiotepa IV over 2 hours on days 1 and 2 Beginning on day 5 the remaining PBSC are reinfused Patients receive G-CSF SC daily beginning on day 5 and continuing until blood counts recover During regimens A B and C G-CSF must be discontinued at least 2 days before administration of any chemotherapy Regimen D After recovery from chemotherapy patients with hormone receptor-positive tumors and no prior refractoriness to hormonal therapies receive oral tamoxifen daily while patients with prior failure on tamoxifen receive oral megestrol 4 times daily Patients undergo irradiation to sites of prior cutaneous nodal bone or soft tissue bulk disease and resection of residual lesions Patients are followed weekly for 1 month biweekly for 2 months monthly for 5 months and then bimonthly for 1 year
PROJECTED ACCRUAL A minimum of 30 patients will be accrued for this study
OUTLINE Patients receive sequential therapy beginning with regimen A Regimen A Patients receive cyclophosphamide IV over 1 hour every 6 hours or more for 4 doses within 36 hours Patients receive filgrastim G-CSF subcutaneously SC daily beginning 2 days after completion of cyclophosphamide and continuing until autologous peripheral blood stem cells PBSC are harvested Regimen B Beginning at least 3 weeks after initiation of regimen A patients receive melphalan IV on days 1 and 2 Beginning on day 4 a portion of the PBSC are reinfused Patients receive G-CSF SC daily beginning on day 4 and continuing until at least day 10 Regimen C Beginning at least 3 weeks after initiation of regimen B patients receive thiotepa IV over 2 hours on days 1 and 2 Beginning on day 5 the remaining PBSC are reinfused Patients receive G-CSF SC daily beginning on day 5 and continuing until blood counts recover During regimens A B and C G-CSF must be discontinued at least 2 days before administration of any chemotherapy Regimen D After recovery from chemotherapy patients with hormone receptor-positive tumors and no prior refractoriness to hormonal therapies receive oral tamoxifen daily while patients with prior failure on tamoxifen receive oral megestrol 4 times daily Patients undergo irradiation to sites of prior cutaneous nodal bone or soft tissue bulk disease and resection of residual lesions Patients are followed weekly for 1 month biweekly for 2 months monthly for 5 months and then bimonthly for 1 year
PROJECTED ACCRUAL A minimum of 30 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-V95-0721 | None | None | None |
| YALE-HIC-7372 | None | None | None |