En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma
- Determine the dose-limiting toxicity and the maximum tolerated dose of autologous
dendritic cells pulsed with autologous tumor cell lysate in patients with stage III or
- Determine the safety and tolerability of this therapy in these patients.
- Determine the immune response, in terms of the type and degree of T-cell proliferation
and delayed-type hypersensitivity responses, in patients treated with this therapy.
OUTLINE: This is a dose-escalation, pilot study.
Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells
(PBMC) on days -9, 19, and 47. Autologous dendritic cells (DC) are prepared from autologous
PBMC exposed to sargramostim (GM-CSF), interleukin-4, and tumor necrosis factor alpha and
pulsed with autologous tumor cell lysate. Patients receive autologous tumor cell
lysate-pulsed DC IV over 5-10 minutes on days 0, 28, and 56.
Cohorts of 3-6 patients receive escalating doses of autologous tumor cell lysate-pulsed DC
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at
which 33% of all patients experience dose-limiting toxicity.
Patients are followed at day 84 and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 3-20
Primary Purpose: Treatment
Christopher P.G. Tretter, MD
Norris Cotton Cancer Center
United States: Federal Government
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|