Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-27 @ 9:48 PM
Study NCT ID:
NCT00045357
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2002-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
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 person's 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:
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?: