Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004178
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2000-01-21
Brief Title:
Gene Therapy in Treating Patients With Cancer
Sponsor:
Roger Williams Medical Center
Organization:
Roger Williams Medical Center
Study Overview
Official Title:
Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors IgTCR in Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2006-05
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 a gene that has been created in the laboratory into a persons white blood cells may make the body build an immune response to kill cancer cells
PURPOSE Phase I trial to study the effectiveness of gene therapy in treating patients who have cancer that has not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of gene therapy in treating patients who have cancer that has not responded to previous therapy
Detailed Description:
OBJECTIVES
Determine the safety and maximum tolerated dose of T cells activated in vitro and modified with chimeric anti-CEA immunoglobulin T cell receptors Ig TCR in patients with CEA expressing adenocarcinoma
Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients
Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR
Assess immunologic parameters which correlate with the efficacy of this regimen in these patients
Evaluate in a preliminary manner the efficacy of this regimen in patients with CEA bearing tumors
OUTLINE This is a dose escalation study
Peripheral blood lymphocytes PBL are harvested PBL are activated in vitro and then modified with recombinant chimeric anti-CEA immunoglobulin T cell receptors Ig TCR Ig TCR modified T cells are reinfused over 30-60 minutes
The estimated maximum tolerated dose MTD is defined as the dose at which 2 of 6 patients experience unacceptable toxicity If the MTD is not reached within the first cohort a second cohort of 3 patients then receives 4 doses of modified T cells at a higher dose
Patients are followed every 2 weeks for 2 months
PROJECTED ACCRUAL A total of 6-9 patients will be accrued for this study
Determine the safety and maximum tolerated dose of T cells activated in vitro and modified with chimeric anti-CEA immunoglobulin T cell receptors Ig TCR in patients with CEA expressing adenocarcinoma
Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients
Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR
Assess immunologic parameters which correlate with the efficacy of this regimen in these patients
Evaluate in a preliminary manner the efficacy of this regimen in patients with CEA bearing tumors
OUTLINE This is a dose escalation study
Peripheral blood lymphocytes PBL are harvested PBL are activated in vitro and then modified with recombinant chimeric anti-CEA immunoglobulin T cell receptors Ig TCR Ig TCR modified T cells are reinfused over 30-60 minutes
The estimated maximum tolerated dose MTD is defined as the dose at which 2 of 6 patients experience unacceptable toxicity If the MTD is not reached within the first cohort a second cohort of 3 patients then receives 4 doses of modified T cells at a higher dose
Patients are followed every 2 weeks for 2 months
PROJECTED ACCRUAL A total of 6-9 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 |
|---|---|---|---|
| NCI-V99-1577 | None | None | None |
| BIDMC-941101148 | None | None | None |
| NEDH-941101148 | None | None | None |