Vaccine Biotherapy Of Cancer: Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma

CDR0000068493

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.

2001-11-01

2009-12-01

2009-12-01

Terminated

Early phase I

9

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 9, 'type': 'ACTUAL'}}

2023-10-04