Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005835
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2000-06-02
Brief Title:
N99-02 Melphalan and Buthionine Sulfoximine
Sponsor:
New Approaches to Neuroblastoma Therapy Consortium
Organization:
New Approaches to Neuroblastoma Therapy Consortium
Study Overview
Official Title:
Modulation of Intensive Melphalan L-PAM by Buthionine Sulfoximine BSO Autologous Stem Cell Support for Resistant or Recurrent High-Risk Neuroblastoma IND 69-112
Status:
COMPLETED
Status Verified Date:
2023-04
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:
BSO
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 bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of melphalan and buthionine sulfoximine followed by bone marrow or peripheral stem cell transplantation in treating children who have resistant or recurrent neuroblastoma
PURPOSE Phase I trial to study the effectiveness of melphalan and buthionine sulfoximine followed by bone marrow or peripheral stem cell transplantation in treating children who have resistant or recurrent neuroblastoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of melphalan when combined with buthionine sulfoximine and followed by autologous bone marrow or peripheral blood stem cell support in children with resistant or recurrent high-risk neuroblastoma
Assess the toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the response rate of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of melphalan
Patients receive buthionine sulfoximine IV as a bolus over 30 minutes followed by a 72-hour continuous infusion beginning on day -4 melphalan IV over 15 minutes on days -3 and -2 autologous peripheral blood stem cells or bone marrow IV over 15-30 minutes on day 0 and filgrastim G-CSF subcutaneously or IV once daily beginning on day 0 and continuing until blood counts recover
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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 84 days and then 2 months later if there is a complete andor partial response Patients who continue therapy on other protocols are followed before starting the new therapy All patients are followed for life for any delayed toxic effects to protocol therapy and secondary malignancies
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 2-3 years
Determine the maximum tolerated dose of melphalan when combined with buthionine sulfoximine and followed by autologous bone marrow or peripheral blood stem cell support in children with resistant or recurrent high-risk neuroblastoma
Assess the toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the response rate of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of melphalan
Patients receive buthionine sulfoximine IV as a bolus over 30 minutes followed by a 72-hour continuous infusion beginning on day -4 melphalan IV over 15 minutes on days -3 and -2 autologous peripheral blood stem cells or bone marrow IV over 15-30 minutes on day 0 and filgrastim G-CSF subcutaneously or IV once daily beginning on day 0 and continuing until blood counts recover
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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 84 days and then 2 months later if there is a complete andor partial response Patients who continue therapy on other protocols are followed before starting the new therapy All patients are followed for life for any delayed toxic effects to protocol therapy and secondary malignancies
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 2-3 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 |
|---|---|---|---|
| NANT-99-02 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01CA081403 |
| P01CA081403 | NIH | None | None |