Vaccine Biotherapy of Cancer: Tumor Cells and Dendritic Cells as Active Specific Immunotherapy of Patients With Metastatic Melanoma
- Determine the safety of immunization with autologous in vitro-treated tumor cells and
dendritic cells in combination with sargramostim (GM-CSF) in patients with stage IV or
- Determine the frequency of conversion of delayed tumor hypersensitivity tests in
patients treated with this regimen.
- Determine the progression-free and overall survival in patients treated with this
- Determine the objective tumor response rate in patients with measurable melanoma
treated with this regimen.
OUTLINE: Patients are stratified according to presence of measurable disease at study
initiation (yes vs no).
Patients undergo tumor cell harvest. Patients with multiple persistent sites of metastatic
disease after harvest may receive systemic therapy (biologic therapy and/or chemotherapy)
during tumor cell line expansion over approximately 4 months. The tumor cell line is
expanded, irradiated, and treated with interferon gamma.
Patients undergo leukapheresis to collect peripheral blood mononuclear cells (PBMC) to
obtain dendritic cells (DC). The PBMC are treated with sargramostim (GM-CSF) and
interleukin-4 for 7 days to produce DC. The DC are then cultured with the treated tumor
cells for 18 hours.
Patients undergo delayed tumor hypersensitivity tests intradermally 1 week prior to
vaccination and again at week 4. Patients receive vaccine therapy comprising autologous
treated tumor cells and dendritic cells suspended in GM-CSF subcutaneously weekly for 3
weeks. Vaccine therapy continues monthly for an additional 5 months in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 3 months for 4 years.
PROJECTED ACCRUAL: A total of 30-80 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety of administration of irradiated autologous tumor cells that have been incubated in vitro with gamma interferon, and subsequently injected subcutaneously with autologous dendritic cells and GMCSF
Robert O. Dillman, MD, FACP
Hoag Memorial Hospital Presbyterian
United States: Food and Drug Administration
|Hoag Cancer Center at Hoag Memorial Hospital Presbyterian||Newport Beach, California 92663|