Expired Study
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Lebanon, New Hampshire 03756


Purpose:

RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's lymphocytes to kill kidney cancer cells. Interferon alfa may interfere with the growth of cancer cells. Combining vaccine therapy with interleukin-2 and interferon alfa may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with interleukin-2 and interferon alfa works in treating patients with metastatic renal cell carcinoma (kidney cancer).


Study summary:

OBJECTIVES: Primary - Determine the clinical response rate in patients with metastatic renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) in combination with interleukin-2 and interferon-alfa. - Determine the toxicity of this regimen in these patients. Secondary - Determine, within relevant immune pathways, the treatment-related, tumor-specific immune response in patients treated with this regimen. - Correlate tumor-specific immune response with objective clinical response in patients treated with this regimen. OUTLINE: - Induction therapy: Patients undergo leukapheresis on day -9. Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by intranodal injection on days 0 and 14; interleukin-2 (IL-2) IV continuously on days 1-5 and 15-19; and interferon-alfa (IFN-α) subcutaneously (SC) once daily on days 1, 3, 5, 15, 17, and 19. - Maintenance therapy: Patients undergo leukapheresis on days 33, 61, and 89. Patients receive DC vaccine by intranodal injection on days 42, 70, and 98; IL-2 IV continuously on days 43-47, 71-75, and 99-103; and IFN-α SC once daily on days 43, 45, 47, 71, 73, 75, 99, 101, and 103. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study.


Criteria:

Inclusion Criteria: - Histologically confirmed metastatic renal cell carcinoma with measurable disease. - Tumor tissue available and properly stored for lysate preparation. - Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or chemotherapy (6 weeks for nitrosureas) and recovered from all ill effects. - Karnofsky Performance Status ≥60% - Life expectancy ≥ twelve weeks - Adequate end organ function: - Hematological: ANC ≥ 1000cells/μL, platelets ≥ 75,000/μL, hemoglobin ≥ 8.5 g/dl - Liver: AST < 2 x ULN (upper limit of normal) unless due to metastases then < 5 x ULN, serum total bilirubin < 2 x ULN (except for patients with Gilbert's Syndrome) - Renal: serum creatinine < 2.0 x ULN. - Pulmonary: FEV1 > 2.0 liters or > 75% of predicted for height and age. - Cardiac: No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, or serious cardiac arrhythmias. Patients over 40 or have had previous myocardial infarction greater than 6 months prior to entry will be required to have a negative or low probability cardiac stress test for cardiac ischemia. - CNS: No history of brain metastases. - Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study. - Appropriate Contraception in both sexes EXCLUSION CRITERIA: - Patients may have not have been treated previously with IL-2, IFNα or autologous vaccine. - Concomitant second malignancy except for non-melanoma skin cancer, and non- invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence, breast CIS. - In patients with a prior history of invasive malignancy, less than five years in complete remission - Positive serology for HIV, hepatitis B or hepatitis C, - Significant co-morbid illness such as uncontrolled diabetes or active infection that would preclude treatment on this regimen. - Use of corticosteroids or other immunosuppression (if patient had been taking steroids, at least 4 weeks must have passed since the last dose). - History of autoimmune disease.


NCT ID:

NCT00085436


Primary Contact:

Study Chair
Marc S. Ernstoff, MD
Norris Cotton Cancer Center


Backup Contact:

N/A


Location Contact:

Lebanon, New Hampshire 03756
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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