Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002594
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Bone Marrow andor Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Dose-Intensive Melphalan and Cyclophosphamide With Autologous Bone Marrow Rescue for Recurrent Medulloblastoma and Germ Cell Tumors
Status:
COMPLETED
Status Verified Date:
2014-07
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 that they stop growing or die bone marrow transplantation and 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 combination chemotherapy followed by bone marrow transplantation andor peripheral stem cell transplantation in treating patients who have recurrent medulloblastoma or CNS germ cell tumors
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow transplantation andor peripheral stem cell transplantation in treating patients who have recurrent medulloblastoma or CNS germ cell tumors
Detailed Description:
OBJECTIVES
Determine the response and progression-free survival in patients with recurrent medulloblastoma or CNS germ cell tumors treated with intensive melphalan and cyclophosphamide followed by autologous bone marrow andor peripheral blood stem cell rescue
Determine the acute and delayed toxic effects of this regimen in these patients
OUTLINE Autologous bone marrow andor peripheral blood stem cells PBSC are harvested Patients then receive intensive cyclophosphamide IV over 1 hour on days -8 to -5 and melphalan IV over 15 minutes on days -4 to -2 Bone marrow is reinfused on day 0 PBSC are reinfused on day 0 if used alone or on day 1 if used after autologous bone marrow transplantation ABMT Sargramostim GM-CSF is administered IV over 2 hours daily beginning 4 hours after ABMT and continuing until blood counts recover
Patients are followed every 6 months through year 4 and then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 25 years
Determine the response and progression-free survival in patients with recurrent medulloblastoma or CNS germ cell tumors treated with intensive melphalan and cyclophosphamide followed by autologous bone marrow andor peripheral blood stem cell rescue
Determine the acute and delayed toxic effects of this regimen in these patients
OUTLINE Autologous bone marrow andor peripheral blood stem cells PBSC are harvested Patients then receive intensive cyclophosphamide IV over 1 hour on days -8 to -5 and melphalan IV over 15 minutes on days -4 to -2 Bone marrow is reinfused on day 0 PBSC are reinfused on day 0 if used alone or on day 1 if used after autologous bone marrow transplantation ABMT Sargramostim GM-CSF is administered IV over 2 hours daily beginning 4 hours after ABMT and continuing until blood counts recover
Patients are followed every 6 months through year 4 and then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 25 years
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 |
|---|---|---|---|
| CDR0000063784 | OTHER | NCI | None |
| COG-P9430 | OTHER | None | None |
| POG-9430 | OTHER | None | None |