Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006225
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2000-09-11
Brief Title:
Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Ex Vivo Expanded Megakaryocytes for Supportive Care of Breast Cancer Patients A Phase III Study
Status:
COMPLETED
Status Verified Date:
2012-05
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 Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy
PURPOSE Randomized phase III trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have breast cancer or hematologic cancer
PURPOSE Randomized phase III trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have breast cancer or hematologic cancer
Detailed Description:
OBJECTIVES
Determine the toxicity of ex vivo expanded megakaryocytes EVE MK as a supplement to peripheral blood stem cell PBSC transplantation in patients with breast cancer or hematologic malignancies
Compare the effect of this treatment regimen on platelet recovery and platelet function in these patients vs historical controls
Compare the frequency of malignant cells in the EVE MK vs the uncultured PBSC collection in these patients
Determine the optimal time of MK harvest for the production of platelets in vivo
Determine the required number of MKs for clinical efficacy in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 durations of CD34 culture times 6 days vs 9 days
After an initial harvest of filgrastim G-CSF-mobilized autologous peripheral blood stem cells PBSC for transplantation patients receive one additional dose of G-CSF and undergo one additional apheresis The CD34 cells are cultured in the presence of recombinant human thrombopoietin interleukin-3 and flt3 ligand to expand megakaryocytes Patients then undergo treatment with high-dose chemotherapy and in some cases total body irradiation followed by reinfusion of the conventional PBSC harvest and the ex vivo expanded megakaryocytes
Patients are followed until blood counts recover
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Determine the toxicity of ex vivo expanded megakaryocytes EVE MK as a supplement to peripheral blood stem cell PBSC transplantation in patients with breast cancer or hematologic malignancies
Compare the effect of this treatment regimen on platelet recovery and platelet function in these patients vs historical controls
Compare the frequency of malignant cells in the EVE MK vs the uncultured PBSC collection in these patients
Determine the optimal time of MK harvest for the production of platelets in vivo
Determine the required number of MKs for clinical efficacy in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 durations of CD34 culture times 6 days vs 9 days
After an initial harvest of filgrastim G-CSF-mobilized autologous peripheral blood stem cells PBSC for transplantation patients receive one additional dose of G-CSF and undergo one additional apheresis The CD34 cells are cultured in the presence of recombinant human thrombopoietin interleukin-3 and flt3 ligand to expand megakaryocytes Patients then undergo treatment with high-dose chemotherapy and in some cases total body irradiation followed by reinfusion of the conventional PBSC harvest and the ex vivo expanded megakaryocytes
Patients are followed until blood counts recover
PROJECTED ACCRUAL A total of 24 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-V00-1611 | None | None | None |
| NU-97B2 | None | None | None |