Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004900
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2000-03-07
Brief Title:
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer
Sponsor:
Hackensack Meridian Health
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Pilot Study of Sequential High Dose Chemotherapy and CD 34 Selected Stem Cell Support Without Conventional-Dose Induction Chemotherapy for Women With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2007-10
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 II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES I Assess the toxicity and response rates to sequential high dose chemotherapy without induction chemotherapy in women with metastatic breast cancer II Determine the hematopoietic recovery rate in these patients after infusion of blood derived CD34 progenitors isolated using a CD34 affinity device for positive purification of the autograft III Compare response rates and duration of responses between these patients treated in this trial to patients treated in a previous trial using the same sequential high dose chemotherapy with induction conventional dose chemotherapy
OUTLINE Patients receive cyclophosphamide IV daily for 2 days and etoposide IV and cisplatin IV daily for 3 days Filgrastim G-CSF is administered subcutaneously twice daily beginning 24 hours after completion of chemotherapy until the last day of apheresis Upon hematopoietic recovery peripheral blood stem cells PBSC are collected over several days Within 35 days of mobilization chemotherapy patients receive cyclophosphamide IV thiotepa IV and carboplatin IV continuously on days -7 to -4 followed by a 2 day rest period CD34 selected PBSC are reinfused Beginning 4 hours after reinfusion patients receive G-CSF subcutaneously daily until hematopoietic recovery Patients may then receive radiation therapy to sites of prior bulk disease at the discretion of the investigator Within 30 days of hematopoietic recovery or immediately following post transplant radiation therapy patients receive oral anastrazole daily until disease progression Patients are followed monthly for 6 months every 3 months for 1 year every 4-6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
OUTLINE Patients receive cyclophosphamide IV daily for 2 days and etoposide IV and cisplatin IV daily for 3 days Filgrastim G-CSF is administered subcutaneously twice daily beginning 24 hours after completion of chemotherapy until the last day of apheresis Upon hematopoietic recovery peripheral blood stem cells PBSC are collected over several days Within 35 days of mobilization chemotherapy patients receive cyclophosphamide IV thiotepa IV and carboplatin IV continuously on days -7 to -4 followed by a 2 day rest period CD34 selected PBSC are reinfused Beginning 4 hours after reinfusion patients receive G-CSF subcutaneously daily until hematopoietic recovery Patients may then receive radiation therapy to sites of prior bulk disease at the discretion of the investigator Within 30 days of hematopoietic recovery or immediately following post transplant radiation therapy patients receive oral anastrazole daily until disease progression Patients are followed monthly for 6 months every 3 months for 1 year every 4-6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 50 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-G00-1689 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067579 | REGISTRY | None | None |