Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003926
Status:
TERMINATED
Last Update Posted:
2017-11-29
First Post:
1999-11-01
Brief Title:
Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
A Phase I Study of the Chemoprotectant Amifostine With Autologous Stem Cell Transplantation for High Risk or Relapsed Pediatric Solid Tumors and Brain Tumors
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn due to slow accrual
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 Chemoprotective drugs such as amifostine may protect normal cells from the side effects of high-dose chemotherapy
PURPOSE Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors
PURPOSE Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors
Detailed Description:
OBJECTIVES
Determine the dose-limiting toxicity of amifostine chemoprotection with peripheral blood stem cell transplantation plus chemotherapy in patients with high-risk or relapsed solid tumors or brain tumors
Determine response or time to disease progression in patients treated with this regimen
OUTLINE This is a dose-escalation study of amifostine Patients are stratified according to age 1 to 18 vs 19 to 45 years
All patients receive filgrastim G-CSF IV for 1 week On day 6 of G-CSF administration patients undergo peripheral blood stem cell PBSC harvest followed by chemotherapy
Patients receive oral busulfan every 6 hours on days -8 to -6 followed by melphalan IV over 30 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2 Patients receive amifostine IV over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1 PBSC are reinfused on day 0
Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed on day 50 at 3 6 and 9 months and at 1 2 and 3 years post PBSC transplantation
PROJECTED ACCRUAL A maximum of 60 patients 30 per stratum will be accrued for this study within 3 years
Determine the dose-limiting toxicity of amifostine chemoprotection with peripheral blood stem cell transplantation plus chemotherapy in patients with high-risk or relapsed solid tumors or brain tumors
Determine response or time to disease progression in patients treated with this regimen
OUTLINE This is a dose-escalation study of amifostine Patients are stratified according to age 1 to 18 vs 19 to 45 years
All patients receive filgrastim G-CSF IV for 1 week On day 6 of G-CSF administration patients undergo peripheral blood stem cell PBSC harvest followed by chemotherapy
Patients receive oral busulfan every 6 hours on days -8 to -6 followed by melphalan IV over 30 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2 Patients receive amifostine IV over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1 PBSC are reinfused on day 0
Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed on day 50 at 3 6 and 9 months and at 1 2 and 3 years post PBSC transplantation
PROJECTED ACCRUAL A maximum of 60 patients 30 per stratum will be accrued for this study within 3 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 |
|---|---|---|---|
| UMN-9712M00074 | OTHER | IRB University of Minnesota | None |
| UMN-MT-9713 | OTHER | None | None |