Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002836
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
1999-11-01
Brief Title:
Filgrastim Plus Chemotherapy Compared With Filgrastim Alone In Treating Women Undergoing Peripheral Stem Cell Transplantation For Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase III Randomized Comparison of High Dose Chemotherapy G-CSF To G-CSF For Mobilization of Peripheral Blood Stem Cells For Autologous Transplantation For Patients With Responsive Metastatic Breast Cancer Or High Risk Stage II-III Patients
Status:
COMPLETED
Status Verified Date:
2018-11
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 Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells It is not yet known which treatment regimen is more effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy plus filgrastim with filgrastim alone in treating women undergoing peripheral stem cell transplantation for stage II stage III or metastatic breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy plus filgrastim with filgrastim alone in treating women undergoing peripheral stem cell transplantation for stage II stage III or metastatic breast cancer
Detailed Description:
OBJECTIVES
I Determine whether high dose chemotherapy in addition to growth factors increases the yield of filgrastim mobilized progenitor cells
II Determine the kinetics of hematopoietic reconstitution following myeloablative therapy and mobilized blood stem cell transplantation
III Determine whether the use of high dose chemotherapy in addition to growth factors for mobilization of stem cells reduces risk of relapse as measured by time to progression in responsive relapsed breast cancer patients receiving autologous peripheral blood stem cell or bone marrow transplants
IV Determine the morbidity and cost differences of the use of high dose chemotherapy plus growth factors compared to growth factors alone for mobilization of peripheral blood progenitors and treatment of breast cancer with high dose chemotherapy
OUTLINE Patients will be randomized into 2 groups Group 1 patients undergo CVP chemotherapy treatment by vein IV on days 1-3 with cyclophosphamide CTX etoposide and cisplatin Filgrastim SC subcutaneously is given on day 4 every 12 hours until completion of apheresis Group 2 patients only receive filgrastim SC given on day 1 every 12 hours until completion of apheresis Stem cells are removed beginning on day 4 for a maximum of 6 days Upon recovery of hematopoiesis patients then receive high IV doses of CBT chemotherapy with CTX carmustine and thiotepa for 3 days followed 4 days later by autologous stem cell reinfusion Beginning on day of reinfusion filgrastim is given bid until WBC reaches a safe level Patients are followed for 90 days posttransplant and then followed indefinitely for antitumor response and time to progression
PROJECTED ACCRUAL This study will include about 218 patients
I Determine whether high dose chemotherapy in addition to growth factors increases the yield of filgrastim mobilized progenitor cells
II Determine the kinetics of hematopoietic reconstitution following myeloablative therapy and mobilized blood stem cell transplantation
III Determine whether the use of high dose chemotherapy in addition to growth factors for mobilization of stem cells reduces risk of relapse as measured by time to progression in responsive relapsed breast cancer patients receiving autologous peripheral blood stem cell or bone marrow transplants
IV Determine the morbidity and cost differences of the use of high dose chemotherapy plus growth factors compared to growth factors alone for mobilization of peripheral blood progenitors and treatment of breast cancer with high dose chemotherapy
OUTLINE Patients will be randomized into 2 groups Group 1 patients undergo CVP chemotherapy treatment by vein IV on days 1-3 with cyclophosphamide CTX etoposide and cisplatin Filgrastim SC subcutaneously is given on day 4 every 12 hours until completion of apheresis Group 2 patients only receive filgrastim SC given on day 1 every 12 hours until completion of apheresis Stem cells are removed beginning on day 4 for a maximum of 6 days Upon recovery of hematopoiesis patients then receive high IV doses of CBT chemotherapy with CTX carmustine and thiotepa for 3 days followed 4 days later by autologous stem cell reinfusion Beginning on day of reinfusion filgrastim is given bid until WBC reaches a safe level Patients are followed for 90 days posttransplant and then followed indefinitely for antitumor response and time to progression
PROJECTED ACCRUAL This study will include about 218 patients
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 |
|---|---|---|---|
| CDR0000065048 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-DM-95047 | OTHER | None | None |
| NCI-G96-1014 | None | None | None |