Treatment of Patients With Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
- Determine whether reinfused activated cells alone or in conjunction with high or
subcutaneous dose interleukin-2 may result in clinical tumor regression in patients
with metastatic melanoma who had previously failed therapy on protocols involving
immunization against the gp100 molecule.
- Determine the survival of infused cells with antitumor activity in these patients.
OUTLINE: This is a salvage regimen.
Patients undergo leukopheresis to obtain peripheral blood mononuclear cells or tumor biopsy
to obtain tumor infiltrating lymphocytes (TIL). Cells are incubated in the presence of
gp209-2M peptide and then harvested and cloned. Patients receive 30-minute IV infusions of
these in vitro sensitized cells. Treatment repeats every 2 weeks for 2 courses. An
additional cohort of 8 patients receives gp209-2M peptide in Montanide ISA-51 subcutaneously
in 2 different sites followed 2 days later by the adoptive transfer of cloned lymphocytes.
At 4 to 6 weeks after the treatment courses, patients with stable or regressing disease may
Patients with disease progression after 2 courses may receive 2 additional courses of cell
infusion followed by interleukin-2 (IL-2) on one of two schedules. One cohort of patients
receives IL-2 by intravenous bolus over 15 minutes every 8 hours beginning on the day after
cell infusion and continuing for up to 5 days of each treatment course. Another cohort
receives IL-2 by daily subcutaneous injections on days 1-12 of each course of therapy. If
after 12-16 patients have been treated with cloned cells alone initially and responses are
inadequate, subsequent patients entered into this study are randomized to receive the cell
infusion followed by IL-2 on one of the two described schedules.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: A total of 91 patients will be accrued for this study over 2 years.
Primary Purpose: Treatment
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|