Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT00045357
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.
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.
Study:
NCT00045357
Study Brief:
Protocol Section:
NCT00045357