Interleukin 12-Primed Activated T Cells As Therapy For Patients With Metastatic Melanoma (Phase I)

Brief Summary

Detailed Description

OBJECTIVES: * Determine the safety of interleukin-12-primed activated T cells (12ATC) and temozolomide in patients with metastatic melanoma. * Determine the maximum tolerated dose of 12ATC in this patient population. * Determine the clinical response of patients treated with this regimen. OUTLINE: This is a dose-escalation study of interleukin-12-primed activated T cells (12ATC). Patients undergo leukopheresis on days 1-3 until adequate peripheral blood mononuclear cells (PBMC) are obtained. The PBMC are treated in vitro over 2 weeks with monoclonal antibody anti-CD3, interleukin-2, and interleukin-12 to form 12ATC. Patients receive oral temozolomide on days 15-19 and 43-47 and 12ATC IV over 15-30 minutes on days 22, 25, 29, 32, 36, 39, 50, 53, 57, 60, 64, and 67 in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 12ATC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 patients experience dose-limiting toxicity. Patients are followed weekly for 2 weeks, every 3 months for 1 year, and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.

Primary Outcomes