Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002942
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
1999-11-01
Brief Title:
Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Randomized Phase III Trial of G-CSF Primed Autologous Bone Marrow Versus Peripheral Blood Progenitor Cells PBPC as Hematopoietic Support for High-Dose Cyclophosphamide Thiotepa and Carboplatin CTCb Therapy in Poor Prognosis Breast Cancer
Status:
COMPLETED
Status Verified Date:
2018-08
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 autologous bone marrow transplantation or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Randomized phase III trial to compare bone marrow transplantation with peripheral stem cell transplantation following carboplatin in treating patients with breast cancer
PURPOSE Randomized phase III trial to compare bone marrow transplantation with peripheral stem cell transplantation following carboplatin in treating patients with breast cancer
Detailed Description:
OBJECTIVES I Compare engraftment rates using G-CSF primed autologous bone marrow vs PBCP as hematopoietic support following high dose CTCb for patients with poor prognosis breast cancer II Compare the complications of these two methods of hematopoietic progenitor cell collections III Compare Stage IV patients with bone or bone marrow involvement assigned to PBPC collections with Stage IV patients randomized to PBPC collections relative to the number of leukaphereses needed to collect the required number of progenitor cells as well as assess engraftment rates between these two groups IV Assess the response to high dose CTCb in this group of patients
OUTLINE All patients will receive G-CSF priming therapy for 5 consecutive days Patients will then be randomized into two treatment arms Arm 1 consists of autologous PBPC collection Arm 2 consists of autologous bone marrow collection Within 2 weeks after progenitor cell collection all patients will receive high dose CTCb therapy by continuous infusion for 5 days followed by autologous hematopoietic progenitor cell infusion at least three days later G-CSF will also be given after infusion until ANC count is over 5000 or over 1000 for 3 consecutive days
PROJECTED ACCRUAL 66 patients will be accrued at a rate of 24 per year
OUTLINE All patients will receive G-CSF priming therapy for 5 consecutive days Patients will then be randomized into two treatment arms Arm 1 consists of autologous PBPC collection Arm 2 consists of autologous bone marrow collection Within 2 weeks after progenitor cell collection all patients will receive high dose CTCb therapy by continuous infusion for 5 days followed by autologous hematopoietic progenitor cell infusion at least three days later G-CSF will also be given after infusion until ANC count is over 5000 or over 1000 for 3 consecutive days
PROJECTED ACCRUAL 66 patients will be accrued at a rate of 24 per year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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-G97-1145 | None | None | None |
| CCCWFU-95496 | None | None | None |