Expired Study
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Tampa, Florida 33612


Purpose:

RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage IV kidney cancer.


Study summary:

OBJECTIVES: - Determine the percentage of patients with stage IV renal cell carcinoma with a reduction in tumor size after treatment with B7-1 gene-modified autologous tumor cell vaccine and interleukin-2. - Determine the immunogenicity of this regimen in these patients. - Determine the overall survival of patients treated with this regimen. - Determine the local and systemic toxicity of this regimen in these patients. OUTLINE: Tumor tissue for vaccine preparation is obtained when patients undergo palliative surgical resection of primary tumor or therapeutic resection of metastasis. At approximately 3-6 weeks after surgery, patients receive B7-1 gene-modified autologous tumor cell vaccine subcutaneously (SC) once on days 1, 29, and 57. At 6 weeks after the first vaccination, patients receive interleukin-2 (IL-2) SC five days a week for 6 weeks (days 43-82). Patients with stable or responding disease after day 106 may receive additional vaccinations in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks after the last dose of IL-2. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed stage IV renal cell carcinoma - Symptomatic primary tumor or resectable metastasis - Measurable disease post resection - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Eastern Cooperative Oncology Group (ECOG) 0-1 Life expectancy: - Not specified Hematopoietic: - WBC greater than 4,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 10 g/dL - Hematocrit greater than 30% Hepatic: - Bilirubin less than 2 times normal - SGOT less than 3 times normal Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No evidence of active myocardial ischemia, prior myocardial infarction, or arrhythmia Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No contraindications to surgical resection - No history of immunodeficiency disease - No known allergy to penicillin PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior interleukin-2, interferon alfa, or other biologic agent allowed Chemotherapy: - Not specified Endocrine therapy: - No concurrent corticosteroids (except for replacement doses for adrenal insufficiency) Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - No concurrent immunosuppressants


NCT ID:

NCT00031564


Primary Contact:

Principal Investigator
Scott J. Antonia, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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