Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003173
Status:
COMPLETED
Last Update Posted:
2013-03-07
First Post:
1999-11-01
Brief Title:
High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
High-Dose Thiotepa With Autologous Stem Cell Rescue in Patients With Malignancies Refractory to Conventional Chemotherapy
Status:
COMPLETED
Status Verified Date:
2013-03
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 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 high-dose thiotepa plus peripheral stem cell transplantation in treating patients with refractory solid tumors
PURPOSE Phase II trial to study the effectiveness of high-dose thiotepa plus peripheral stem cell transplantation in treating patients with refractory solid tumors
Detailed Description:
OBJECTIVES
Evaluate the efficacy and toxicity of sequential cycles of high dose thiotepa with stem cell rescue and filgrastim in patients with malignancies refractory to conventional chemotherapy or for whom conventional therapy is not available
Evaluate the effectiveness of autologous stem cells in restoring hematopoiesis following high dose thiotepa
OUTLINE Patients are stratified by type of tumor neuroectodermal CNS tumor vs non-neuroectodermal CNS tumor vs non-CNS small round blue cell tumor vs other non-CNS tumor
Autologous stem cells are obtained prior to the administration of thiotepa Patients who do not have peripheral blood stem cells available may undergo a bone marrow harvest instead Thiotepa is administered as a 3 hour infusion daily for 3 consecutive days Stem cells are reinfused approximately 72 hours following the completion of thiotepa Filgrastim is administered the day following reinfusion of stem cells and continues until there is sufficient hematopoietic recovery
The second course of thiotepa is administered 4 weeks following the first course in patients who have responding or stable disease adequate stem cells and no unacceptable toxicity Patients receive a maximum of 2 courses
PROJECTED ACCRUAL Approximately 36 patients will be accrued for this study over 2 years
Evaluate the efficacy and toxicity of sequential cycles of high dose thiotepa with stem cell rescue and filgrastim in patients with malignancies refractory to conventional chemotherapy or for whom conventional therapy is not available
Evaluate the effectiveness of autologous stem cells in restoring hematopoiesis following high dose thiotepa
OUTLINE Patients are stratified by type of tumor neuroectodermal CNS tumor vs non-neuroectodermal CNS tumor vs non-CNS small round blue cell tumor vs other non-CNS tumor
Autologous stem cells are obtained prior to the administration of thiotepa Patients who do not have peripheral blood stem cells available may undergo a bone marrow harvest instead Thiotepa is administered as a 3 hour infusion daily for 3 consecutive days Stem cells are reinfused approximately 72 hours following the completion of thiotepa Filgrastim is administered the day following reinfusion of stem cells and continues until there is sufficient hematopoietic recovery
The second course of thiotepa is administered 4 weeks following the first course in patients who have responding or stable disease adequate stem cells and no unacceptable toxicity Patients receive a maximum of 2 courses
PROJECTED ACCRUAL Approximately 36 patients will be accrued for this study over 2 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 |
|---|---|---|---|
| NCI-G97-1366 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |
| MSKCC-97089A3 | None | None | None |
| NYU-97-7 | None | None | None |