Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045357
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2002-09-06
Brief Title:
Biological Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4 Antigen-Specific T Cell Clones for Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2010-09
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 white blood cells in the laboratory and reinfusing them may cause a stronger immune response and kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma
PURPOSE Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of autologous CD4 antigen-specific T-cells for cellular adoptive immunotherapy in patients with metastatic melanoma
Determine the safety and toxicity of this regimen in these patients
Determine the duration of in vivo persistence of adoptively transferred CD4 antigen-specific T-cell clones in these patients
Secondary
Determine the antitumor effects of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients undergo leukapheresis to collect peripheral blood mononuclear cells CD4 antigen-specific T-cell clones are generated over the next 2-3 months using immunogenic peptides MART1 tyrosinase or gp100
Patients receive autologous CD4 antigen-specific T-cells IV over 30 minutes
Cohorts of 3-6 patients receive escalating doses of autologous CD4 antigen-specific T-cells until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed on days 1 and 3 post T-cell infusion and then once weekly for 12 weeks
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of autologous CD4 antigen-specific T-cells for cellular adoptive immunotherapy in patients with metastatic melanoma
Determine the safety and toxicity of this regimen in these patients
Determine the duration of in vivo persistence of adoptively transferred CD4 antigen-specific T-cell clones in these patients
Secondary
Determine the antitumor effects of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients undergo leukapheresis to collect peripheral blood mononuclear cells CD4 antigen-specific T-cell clones are generated over the next 2-3 months using immunogenic peptides MART1 tyrosinase or gp100
Patients receive autologous CD4 antigen-specific T-cells IV over 30 minutes
Cohorts of 3-6 patients receive escalating doses of autologous CD4 antigen-specific T-cells until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed on days 1 and 3 post T-cell infusion and then once weekly for 12 weeks
PROJECTED ACCRUAL A total of 3-18 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 |
|---|---|---|---|
| CDR0000256867 | REGISTRY | PDQ | None |
| FHCRC-158500 | None | None | None |
| NCI-H02-0093 | None | None | None |