Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002748
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
1999-11-01
Brief Title:
Gene Therapy in Treating Children With Refractory or Recurrent Neuroblastoma
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Phase I Study of Cytokine-Gene Modified Autologous or Partially Matched Allogeneic Neuroblastoma Cells for Treatment of RelapsedRefractory Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2011-10
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 Inserting the gene for interleukin-2 into a persons neuroblastoma cells may make the body build an immune response and kill tumor cells
PURPOSE Phase I trial to study the effectiveness of using interleukin-2 gene-modified neuroblastoma cells in treating children who have refractory or recurrent neuroblastoma
PURPOSE Phase I trial to study the effectiveness of using interleukin-2 gene-modified neuroblastoma cells in treating children who have refractory or recurrent neuroblastoma
Detailed Description:
OBJECTIVES I Determine the safety in children of recurrent neuroblastoma of two weekly subcutaneous injections of autologous or partially HLA-matched allogeneic neuroblastoma cells that have been modified by insertion of the interleukin-2 gene introduced by a retroviral vector II Determine whether multiple histocompatibility-restricted or unrestricted antitumor immune responses are induced by this treatment and the cell dose required to produce these effects III Obtain preliminary data on the antitumor effects of this regimen
OUTLINE Autologous or partially HLA-matched allogeneic neuroblastoma cells are transduced with a human gene for interleukin-2 production Patients receive subcutaneous injections of the gene-modified cells on days 1 and 8 with the second injection containing 10 times more cells than the first injection After a 3-4 week rest stable and responding patients may receive additional weekly injections at the second dose Cohorts of 3-6 patients will be entered at increasing cell doses until the maximum tolerated dose is estimated Multiple injection sites may be used at the higher cell-dose levels Patients are followed every week for 6 weeks every other week for 6 weeks and monthly for 1 year Additional visits may be required as clinically indicated
PROJECTED ACCRUAL Approximately 12 patients each will be entered into the autologous and the partially HLA-matched allogeneic tumor cell treatment groups Accrual is expected to require 4 years for the autologous tumor cell group and 2 years for the partially HLA-matched allogenic tumor cell group
OUTLINE Autologous or partially HLA-matched allogeneic neuroblastoma cells are transduced with a human gene for interleukin-2 production Patients receive subcutaneous injections of the gene-modified cells on days 1 and 8 with the second injection containing 10 times more cells than the first injection After a 3-4 week rest stable and responding patients may receive additional weekly injections at the second dose Cohorts of 3-6 patients will be entered at increasing cell doses until the maximum tolerated dose is estimated Multiple injection sites may be used at the higher cell-dose levels Patients are followed every week for 6 weeks every other week for 6 weeks and monthly for 1 year Additional visits may be required as clinically indicated
PROJECTED ACCRUAL Approximately 12 patients each will be entered into the autologous and the partially HLA-matched allogeneic tumor cell treatment groups Accrual is expected to require 4 years for the autologous tumor cell group and 2 years for the partially HLA-matched allogenic tumor cell group
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-H96-0005 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA021765 |
| U01CA058211 | NIH | None | None |
| P30CA021765 | NIH | None | None |
| SJCRH-CYGENE | None | None | None |
| SJCRH-CYGNE2 | None | None | None |