Phase II Randomized Study of CD34+ Derived or Peripheral Monocyte Derived Dendritic Cells Pulsed With MART-1 and gp100 Melanoma Antigens in Patients With High Risk Stage III or Completely Resected Metastatic Melanoma
I. Determine the immunologic activity of CD34+ derived and peripheral monocyte derived
dendritic cells pulsed with MART-1 and gp100 melanoma antigens in patients with high risk
stage III or completely resected metastatic melanoma.
PROTOCOL OUTLINE: This is a randomized study. Patients receive dendritic cells derived
either from peripheral monocytes or CD34+ cells.
Dendritic cells are pulsed with MART-1 and gp100 immunodominant HLA-A201 peptides prior to
infusion, and are administered intralymphatically in the lower extremities for the first 2
courses. Beginning with courses 3 and 4, dendritic cells are administered subcutaneously in
the anterior thigh. Dendritic cells are not administered to any extremity that has undergone
lymph node dissection.
Patients are randomized to the following treatment arms:
Arm I: Patients undergo leukapheresis to obtain peripheral monocytes. Patients receive
dendritic cells derived from peripheral mononuclear cells pulsed with MART-1 and gp100 every
4 weeks for up to 4 courses.
Arm II: Patients receive 5 daily subcutaneous injections of filgrastim (G-CSF) followed by
leukapheresis on days 5 and/or 6. Patients receive dendritic cells derived from CD34+ cells
pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses.
Patients are followed at 4 to 6 weeks.
A maximum of 28 patients (14 per treatment arm) will be accrued for this study within 7
Primary Purpose: Treatment
National Cancer Institute (NCI)
United States: Federal Government