Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002515
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers
Status:
COMPLETED
Status Verified Date:
2013-06
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 Bone marrow transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with thiotepa carboplatin and topotecan followed by bone marrow transplantation in treating patients who have metastatic or progressive rare cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with thiotepa carboplatin and topotecan followed by bone marrow transplantation in treating patients who have metastatic or progressive rare cancer
Detailed Description:
OBJECTIVES
Improve the long term disease-free survival of patients with rare cancers at high risk for lethal relapse by using myeloablative chemotherapy with thiotepa carboplatin and topotecan followed by autologous bone marrow or peripheral blood stem cell rescue
OUTLINE Autologous bone marrow or peripheral blood stem cells PBSC are harvested Patients receive high-dose thiotepa IV over 3 hours on days -8 to -6 carboplatin IV over 4 hours on days -5 to -3 and topotecan IV over 30 minutes on days -8 to -4 Autologous bone marrow or PBSC are reinfused on day 0 Patients receive filgrastim G-CSF IV twice daily beginning on day 1
Patients are followed for 1 year
PROJECTED ACCRUAL Approximately 50 patients will be accrued for this study within 5 years
Improve the long term disease-free survival of patients with rare cancers at high risk for lethal relapse by using myeloablative chemotherapy with thiotepa carboplatin and topotecan followed by autologous bone marrow or peripheral blood stem cell rescue
OUTLINE Autologous bone marrow or peripheral blood stem cells PBSC are harvested Patients receive high-dose thiotepa IV over 3 hours on days -8 to -6 carboplatin IV over 4 hours on days -5 to -3 and topotecan IV over 30 minutes on days -8 to -4 Autologous bone marrow or PBSC are reinfused on day 0 Patients receive filgrastim G-CSF IV twice daily beginning on day 1
Patients are followed for 1 year
PROJECTED ACCRUAL Approximately 50 patients will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V93-0214 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000078115 | REGISTRY | None | None |