Vaccine Therapy in Treating Patients With Kidney Cancer
Recruitment status was Active, not recruiting
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.
Biological: autologous tumor cell vaccine
Biological: therapeutic autologous dendritic cells
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Vaccine Biotherapy Of Cancer: Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma|
- Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
- Progression-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion [ Designated as safety issue: No ]
- Event-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion [ Designated as safety issue: No ]
- Overall survival beginning at the date of study entry [ Designated as safety issue: No ]
|Study Start Date:||November 2001|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
- 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.
|United States, California|
|Hoag Cancer Center at Hoag Memorial Hospital Presbyterian|
|Newport Beach, California, United States, 92663|
|Study Chair:||Robert O. Dillman, MD, FACP||Hoag Memorial Hospital Presbyterian|