Vaccine Biotherapy Of Cancer: Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma
- Determine the safety of immunization with in vitro-treated autologous tumor cells and
dendritic cells with sargramostim (GM-CSF) in patients with stage III or IV or
recurrent renal cell cancer.
- Determine the frequency of conversion of delayed tumor hypersensitivity tests in these
patients treated with this regimen.
- Determine the progression-free and overall survival of these patients treated with this
- Determine the objective tumor response rate in patients who still have measurable
disease at the time they are treated with this regimen.
OUTLINE: Patients are stratified according to measurable disease at the time vaccine therapy
is initiated (yes vs no).
Patients undergo tumor cell harvest. Patients with multiple persistent sites of metastatic
disease following harvest receive systemic therapy (biologic therapy and/or chemotherapy)
during tumor cell line expansion. Over 2-4 months, the tumor cell line is expanded, treated
with interferon gamma, and irradiated.
Patients undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC). The PBMC
are incubated over 7 days with sargramostim (GM-CSF) and interleukin-4 to produce dendritic
cells (DC). The DC are incubated over 2-3 days with the irradiated tumor cells from the
autologous tumor cell line for antigen loading of the DC.
Patients undergo delayed tumor hypersensitivity testing 1 week prior to vaccination and
again at week 4. Patients receive vaccine therapy comprising autologous treated tumor cells
and DC suspended in GM-CSF subcutaneously weekly for 3 weeks. Vaccine therapy continues
monthly for 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 80 patients (40 per stratum) will be accrued for this study.
Primary Purpose: Treatment
Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy
Robert O. Dillman, MD, FACP
Hoag Memorial Hospital Presbyterian
United States: Federal Government
|Hoag Cancer Center at Hoag Memorial Hospital Presbyterian||Newport Beach, California 92663|