Kidney Cancer Clinical Trial
Vaccine Therapy in Treating Patients With Kidney Cancer
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.
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.
Histologically confirmed renal cell carcinoma
Stage III or IV disease involving invasions beyond Gerota's fascia, regional lymph node involvement, or distant metastases OR
Recurrent disease involving lymph node metastases or soft tissue nodules
Measurable disease by anatomic-based radiological tests (unless no evidence of disease as documented by prior surgery)
Planned resection of tumor to establish an autologous tumor cell line
No active CNS metastases such as brain metastases, spinal cord compression, or leptomeningeal disease
Prior brain metastases or spinal cord compression allowed provided there is radiographic evidence of lack of progression and no requirement for pharmacologic doses of corticosteroids
16 and over
At least 4 months
Hematocrit greater than 25%
Platelet count greater than 100,000/mm3
No ongoing transfusion requirements
No active blood clotting or bleeding diathesis
Bilirubin no greater than 2.0 mg/dL
Albumin at least 3.0 g/dL
No significant hepatic dysfunction
Creatinine no greater than 2.0 mg/dL
No significant renal dysfunction
No underlying cardiac disease associated with New York Heart Association class III or IV heart function
No unstable angina related to atherosclerotic cardiovascular disease
No other malignancy within the past 5 years except carcinoma in situ, basal cell or localized squamous cell skin cancer, or localized prostate cancer
No active infection
No other active medical condition that could be eminently life threatening
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Other prior putative vaccines allowed
Recovered from prior biologic therapy
No concurrent biologic therapy except epoetin alfa for patients with hematocrit less than 36%
At least 3 weeks since prior chemotherapy and recovered
No concurrent chemotherapy
See Disease Characteristics
No concurrent corticosteroids
At least 3 weeks since prior radiotherapy (including whole-brain radiotherapy) and recovered
No concurrent radiotherapy
See Disease Characteristics
Recovered from prior surgery
Concurrent bisphosphonates allowed for patients with lytic bone metastases
No concurrent digoxin or other medications designed to improve cardiac output
No other concurrent anticancer therapy or investigational therapy
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There is 1 Location for this study
Newport Beach California, 92663, United States
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