Phase I Trial of a Dendritic Cell Vaccine for Melanoma
I. Determine the dose-limiting toxicities, maximum tolerated dose, recommended phase II
dose, and rate of sensitization of T cells at each dose level in patients with melanoma
receiving dendritic cell vaccine.
II. Determine the overall (complete and partial) response rate, duration of response, and
optimal route of administration in this patient population.
OUTLINE: This is a dose escalation study. Patients are randomized to one of three treatment
All patients undergo leukopheresis to obtain lymphocyte and myeloid origin mononuclear cell
fractions for preparation of dendritic cell (DC) vaccine. In each arm, cohorts of up to 5
patients receive escalating doses of vaccine. The maximum tolerated dose (MTD) is defined as
the dose preceding that at which 2 or more of 5 patients experience dose-limiting toxicity.
Randomization ceases if the MTD has been reached in 2 arms, although accrual may continue.
Treatment repeats every 2 weeks for a total of 4 doses.
Arm I: Patients receive 3 different doses of peptide pulsed DC vaccine IV, each divided into
3 different peptide pulsed pools administered over 30 minutes.
Arm II: Patients receive 3 different doses of peptide pulsed DC vaccine
subcutaneously/intradermally to sites with no evidence of disease. At the lowest dose,
patients receive 3 different peptide pulsed pools, each administered at a separate site. At
the higher doses, patients receive 3 injections further subdivided into 6 and administered
at 6 distinct sites.
Arm III: Patients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph
nodes at the lower 2 doses of the 3 administered to arms I and II. At the lower dose,
patients receive 3 different peptide pulsed pools, each administered into a different node.
At the higher dose, patients receive 3 injections further subdivided into 6 and administered
at 6 distinct sites.
Patients are followed at 2 weeks and then monthly for 3 months.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Brian J. Czerniecki, MD, PhD
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
|University of Pennsylvania Cancer Center||Philadelphia, Pennsylvania 19104|