Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003743
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
1999-11-01
Brief Title:
Interleukin-2 in Treating Children With Stage IV Neuroblastoma Who Have Received Induction Therapy and Peripheral Stem Cell Transplantation
Sponsor:
St Anna Kinderkrebsforschung
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Multicenter Observer-Blind Randomized Phase II Parallel Study Comparing Three Doses of Subcutaneous Interleukin 2 After Megatherapy and Peripheral Stem Cell Reinfusion in Stage 4 Neuroblastoma in Patients Over 1 Year of Age
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Interleukin-2 may stimulate a persons white blood cells to kill neuroblastoma cells
PURPOSE Phase II trial to study the effectiveness of interleukin-2 in treating children with stage IV neuroblastoma who have received induction therapy and peripheral stem cell transplantation
PURPOSE Phase II trial to study the effectiveness of interleukin-2 in treating children with stage IV neuroblastoma who have received induction therapy and peripheral stem cell transplantation
Detailed Description:
OBJECTIVES I Determine the maximum dose that can be administered in an ambulatory setting among three dose regimens in children with stage IV neuroblastoma II Determine the highest tolerated level if a sustained increase in NK-cell number is observed III Determine the type duration and reversibility of side effects at the three dose levels IV Confirm the chosen dose level
OUTLINE This is a randomized parallel open label multicenter study Part I Patients receive one of three doses of interleukin-2 IL-2 subcutaneously beginning 20 to 40 days following autologous stem cell reinfusion IL-2 is administered for 5 consecutive days every 14 days for up to 3 months for a total of 6 courses Cohorts of 5 patients are entered at each dose level of IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 3 or more patients experience dose limiting toxicity Part II Additional patients receive IL-2 at the dose level below the MTD These patients are stratified according to prior therapy melphalan plus megatherapy vs total body irradiation or meta-iodobenzylguanidine scan plus melphalan vs busulfan containing regimens Patients are followed at 1 week
PROJECTED ACCRUAL Approximately 25 patients will be accrued for this study
OUTLINE This is a randomized parallel open label multicenter study Part I Patients receive one of three doses of interleukin-2 IL-2 subcutaneously beginning 20 to 40 days following autologous stem cell reinfusion IL-2 is administered for 5 consecutive days every 14 days for up to 3 months for a total of 6 courses Cohorts of 5 patients are entered at each dose level of IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 3 or more patients experience dose limiting toxicity Part II Additional patients receive IL-2 at the dose level below the MTD These patients are stratified according to prior therapy melphalan plus megatherapy vs total body irradiation or meta-iodobenzylguanidine scan plus melphalan vs busulfan containing regimens Patients are followed at 1 week
PROJECTED ACCRUAL Approximately 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 |
|---|---|---|---|
| EU-98056 | None | None | None |
| STANNACH-INTERLEUKIN-2 | None | None | None |