Vaccine Therapy in Treating Patients With Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At least 4 months Hematopoietic: Hematocrit greater than 25% Platelet count greater than 100,000/mm3 No ongoing transfusion requirements No active blood clotting or bleeding diathesis Hepatic: Bilirubin no greater than 2.0 mg/dL Albumin at least 3.0 g/dL No significant hepatic dysfunction Renal: Creatinine no greater than 2.0 mg/dL No significant renal dysfunction Cardiovascular: No underlying cardiac disease associated with New York Heart Association class III or IV heart function No unstable angina related to atherosclerotic cardiovascular disease Other: 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 Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic 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% Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent corticosteroids Radiotherapy: At least 3 weeks since prior radiotherapy (including whole-brain radiotherapy) and recovered No concurrent radiotherapy Surgery: See Disease Characteristics Recovered from prior surgery Other: 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
Sites / Locations
- Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
Arms of the Study
Arm 1
Experimental
Biological/Vaccine
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.