A Randomized Phase II Study of Immunization Against Melanoma Comparing Autologous Dendritic Cells Pulsed With gp100 Peptide to Autologous Dendritic Cells Fused With Autologous Tumor Cells
- Compare the tumor-specific immune response, in terms of the number of gp100-specific
cytotoxic T-lymphocytes, T-cell production of interferon gamma, or T-cell proliferation
in response to in vitro exposure to gp100 and tumor lysate, in patients with stage III
or IV melanoma treated with autologous dendritic cells (DC) pulsed with gp100 antigen
vs autologous DC fused with autologous tumor cells.
- Compare the safety and toxicity of these regimens in these patients.
- Compare the therapeutic effect of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
All patients undergo leukapheresis. Peripheral blood mononuclear cells are cultured to
generate dendritic cells (DC).
- Arm I: Patients undergo surgical harvesting of tumor cells for subsequent fusion.
Patients receive vaccination comprising DC fused with autologous tumor cells
subcutaneously on day 1. Treatment repeats every 21 days for 3 courses. Patients who
achieve a partial (PR) or complete response (CR) may receive an additional 3 courses.
- Arm II: Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day
1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may
receive an additional 6 courses.
In both arms, patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this
Allocation: Randomized, Primary Purpose: Treatment
Frank Haluska, MD, PhD
Massachusetts General Hospital
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|