RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent or stage III or stage IV kidney cancer.
OBJECTIVES: * 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 regimen. * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy
Time frame: week 4 and month 6 during vaccine therapy
Tumor response (partial response or complete response) as measured by RECIST at months 2 or 3 and 6 during study treatment, and 6 months after study completion
Time frame: months 2 or 3 and 6 during study treatment, and 6 months after study completion
Progression-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion
Time frame: months 2 or 3 and 6 during study treatment and every 6 months after study completion
Event-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion
Time frame: months 2 or 3 and 6 during study treatment and every 6 months after study completion
Overall survival beginning at the date of study entry
Time frame: 5 years or until death, whichever came first.
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