Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Fred Hutchinson Cancer Center
With
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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
