Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052884
Status:
TERMINATED
Last Update Posted:
2023-06-18
First Post:
2003-01-24
Brief Title:
Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase I Study of Amifostine Followed by High-Dose Escalation of Melphalan With Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual and changes in clinical practice
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 work in different ways to stop the growth of plasma cells either by killing the cells or by stopping them from dividing Having a peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy allows higher dose of chemotherapy to be given so that more plasma cells are killed Giving a chemoprotective drug such as amifostine may protect kidney cells from the side effects of chemotherapy
PURPOSE This phase I trial is studying the side effects and best dose of melphalan given together with amifostine in treating patients who are undergoing peripheral stem cell transplant for primary systemic amyloidosis
PURPOSE This phase I trial is studying the side effects and best dose of melphalan given together with amifostine in treating patients who are undergoing peripheral stem cell transplant for primary systemic amyloidosis
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of high-dose melphalan administered with amifostine in patients with primary systemic amyloidosis undergoing autologous peripheral blood stem cell transplantation
Determine the toxicity of high-dose melphalan when administered at the MTD in these patients
Determine the response rate in patients treated with this regimen
OUTLINE This is a nonrandomized multicenter dose-escalation study of melphalan
Patients receive filgrastim G-CSF subcutaneously once daily until peripheral blood stem cell PBSC collection is complete Apheresis begins on day 5 of G-CSF administration and continues until the target number of PBSCs are collected
Within 6 weeks of PBSC collection patients receive amifostine IV over 5 minutes on days -2 and -1 and high-dose melphalan IV over 30-60 minutes on day -1 Patients undergo autologous PBSC infusion on day 0
Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 10 patients are treated at that dose
Patients are followed approximately 3 months following transplantation then every 6 months for 5 years
PROJECTED ACCRUAL A total of 3-46 patients will be accrued for this study within 23 years
Determine the maximum tolerated dose MTD of high-dose melphalan administered with amifostine in patients with primary systemic amyloidosis undergoing autologous peripheral blood stem cell transplantation
Determine the toxicity of high-dose melphalan when administered at the MTD in these patients
Determine the response rate in patients treated with this regimen
OUTLINE This is a nonrandomized multicenter dose-escalation study of melphalan
Patients receive filgrastim G-CSF subcutaneously once daily until peripheral blood stem cell PBSC collection is complete Apheresis begins on day 5 of G-CSF administration and continues until the target number of PBSCs are collected
Within 6 weeks of PBSC collection patients receive amifostine IV over 5 minutes on days -2 and -1 and high-dose melphalan IV over 30-60 minutes on day -1 Patients undergo autologous PBSC infusion on day 0
Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 10 patients are treated at that dose
Patients are followed approximately 3 months following transplantation then every 6 months for 5 years
PROJECTED ACCRUAL A total of 3-46 patients will be accrued for this study within 23 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 |
|---|---|---|---|
| ECOG-E2A01 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |