Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003425
Status:
COMPLETED
Last Update Posted:
2013-04-26
First Post:
1999-11-01
Brief Title:
Phase III Study of Escalating-Dose Melphalan wAutologous SCS Amifostine Cytoprotect
Sponsor:
University of Kentucky
Organization:
University of Kentucky
Study Overview
Official Title:
Phase III Study of Escalating Dose Melphalan With Autologous Pluripotent Hematopoietic Stem Cell Support and Amifostine Cytoprotection in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2013-04
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 Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Phase III trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation and amifostine in treating patients with cancer
PURPOSE Phase III trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation and amifostine in treating patients with cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of high dose melphalan with autologous peripheral blood stem cell support and amifostine cytoprotection in patients with cancer II Determine the complete response rate event free survival overall survival and nonrelapse mortality in this patient population
OUTLINE This is a dose escalation study of melphalan Prior to high dose melphalan and amifostine cytoprotection patients may receive cyclophosphamide IV Filgrastim G-CSF is given until cytapheresis is completed Patients receive high dose melphalan according to an escalating dose schedule High dose melphalan is administered IV on day -1 Amifostine is also administered on days -2 and -1 Peripheral blood stem cell transplantation is performed on day 0 Dose escalation of high dose melphalan continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose limiting toxicity After the MTD of high dose melphalan is determined additional patients are treated at this dose level Patients are followed at days 30 100 365 and yearly thereafter
PROJECTED ACCRUAL After the determination of MTD a total of 14-25 patients will be accrued for this study
OUTLINE This is a dose escalation study of melphalan Prior to high dose melphalan and amifostine cytoprotection patients may receive cyclophosphamide IV Filgrastim G-CSF is given until cytapheresis is completed Patients receive high dose melphalan according to an escalating dose schedule High dose melphalan is administered IV on day -1 Amifostine is also administered on days -2 and -1 Peripheral blood stem cell transplantation is performed on day 0 Dose escalation of high dose melphalan continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose limiting toxicity After the MTD of high dose melphalan is determined additional patients are treated at this dose level Patients are followed at days 30 100 365 and yearly thereafter
PROJECTED ACCRUAL After the determination of MTD a total of 14-25 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-V98-1455 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066448 | REGISTRY | None | None |
| ALZA-UKMC-97BMT72 | None | None | None |