Interleukin 12-Primed Activated T Cells As Therapy For Patients With Metastatic Melanoma (Phase I)
- 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 Purpose: Treatment
Maximum tolerated dose at completion of study
John P. Hanson, MD
St. Luke's Medical Center
United States: Federal Government
|Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center||Milwaukee, Wisconsin 53201-2901|