Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186862
Status:
COMPLETED
Last Update Posted:
2008-06-03
First Post:
2005-09-12
Brief Title:
Gene Modified Allogeneic Neuroblastoma Cells For Treatment of RelapsedRefractory Neuroblastoma
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Phase I Study of Chemokine and Cytokine Gene Modified Allogeneic Neuroblastoma Cells For Treatment of RelapsedRefractory Neuroblastoma Using a Retroviral Vector
Status:
COMPLETED
Status Verified Date:
2008-06
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:
Neuroblastoma affects approximately 500 children a year in the United States When the tumor occurs in infants it is frequently localized and responds well to therapy Even disseminated disease can be eradicated in about 75 of infants and indeed may undergo spontaneous remission In older children the prognosis is far worse and 80 or more of those with disseminated tumor can be expected to relapse within 3 years
This study will utilize the concept of exploiting the immune system to eradicate neuroblastoma In tumors in which there is consistent expression of tumor specific antigens as part of the malignant process it may be possible to generate immune T-cells ex-vivo or in-vivo by using the specific protein or peptides derived therefrom and eradicate the tumor This study will evaluate the use of four to eight injections of IL-2 gene-transduced autologous neuroblastoma cells to induce a local polyclonal T-cell infiltrate as well as an anti-tumor immune response
This study will utilize the concept of exploiting the immune system to eradicate neuroblastoma In tumors in which there is consistent expression of tumor specific antigens as part of the malignant process it may be possible to generate immune T-cells ex-vivo or in-vivo by using the specific protein or peptides derived therefrom and eradicate the tumor This study will evaluate the use of four to eight injections of IL-2 gene-transduced autologous neuroblastoma cells to induce a local polyclonal T-cell infiltrate as well as an anti-tumor immune response
Detailed Description:
Secondary objectives for this protocol included the following
To determine whether major histocompatibility complex MHC restricted or unrestricted antitumor immune responses are induced by injection of modified allogeneic neuroblasts and the cell doses required to produce these effects
To obtain preliminary data on the antitumor effects of this treatment regimen
To determine whether major histocompatibility complex MHC restricted or unrestricted antitumor immune responses are induced by injection of modified allogeneic neuroblasts and the cell doses required to produce these effects
To obtain preliminary data on the antitumor effects of this treatment regimen
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