Finding studies
Finding studies
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Lead
Fred Hutchinson Cancer Center
PRIMARY OBJECTIVES: I. To assess the safety and toxicity of cellular adoptive immunotherapy in melanoma patients using autologous CD4+ and CD8+ antigen-specific T cell clones. II. To evaluate the antitumor effects of CD4+ and CD8+ antigen-specific T cells in patients with metastatic melanoma. III. To determine the duration of in vivo persistence of adoptively transferred CD8+ antigen-specific T cell clones in the presence or absence of transferred CD4+ T cells. SECONDARY OBJECTIVES: I. To assess the in vivo antitumor efficacy of the infused autologous antigen-specific CD4+ T cells. OUTLINE: This is a phase I study followed by a phase II study. Beginning 48 hours before T-cell infusion, patients receive cyclophosphamide IV. Patients then receive antigen-specific CD8+ T cells IV alone or with CD4+ T helper clones over 1-2 hours on day 0. Patients also receive aldesleukin subcutaneously twice daily on days 0-13. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up weekly for 8 weeks, and then periodically thereafter.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
