Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039299
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2002-06-06
Brief Title:
Biological Therapy in Treating Patients With Prostate Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Safety Study Of Xcellerate In Patients With Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2003-06
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:
RATIONALE Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing Treating a persons T cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of T-cell therapy in treating patients who have prostate cancer that has not responded to hormone therapy
PURPOSE Phase I trial to study the effectiveness of T-cell therapy in treating patients who have prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Determine the safety of activated autologous T cells Xcellerate therapy in patients with hormone-refractory prostate cancer
Determine the change in prostate-specific antigen PSA levels in patients treated with this therapy
Determine the effects on bone in patients treated with this therapy
OUTLINE This is a multicenter study
Patients undergo leukapheresis to collect peripheral blood mononuclear cells PBMC PBMC are activated and expanded ex vivo by costimulation with antihuman CD3 and antihuman CD28 monoclonal antibodies covalently attached to superparamagnetic microbeads Xcellerate Xcellerate-activated T cells are reinfused on day 0
Patients are followed weekly for 4 weeks and then monthly for 3 months
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
Determine the safety of activated autologous T cells Xcellerate therapy in patients with hormone-refractory prostate cancer
Determine the change in prostate-specific antigen PSA levels in patients treated with this therapy
Determine the effects on bone in patients treated with this therapy
OUTLINE This is a multicenter study
Patients undergo leukapheresis to collect peripheral blood mononuclear cells PBMC PBMC are activated and expanded ex vivo by costimulation with antihuman CD3 and antihuman CD28 monoclonal antibodies covalently attached to superparamagnetic microbeads Xcellerate Xcellerate-activated T cells are reinfused on day 0
Patients are followed weekly for 4 weeks and then monthly for 3 months
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0111008 | None | None | None |
| CDR0000069370 | REGISTRY | None | None |
| XCYTE-XT002 | None | None | None |
| NCI-G02-2075 | Registry Identifier | PDQ Physician Data Query | None |