DC Vaccine Combined With IL-2 and IFNα-2a in Treating Patients With mRCC
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms
Intervention: Aldesleukin,; autologous tumor cell vaccine; recombinant interferon alfa
Intervention description: Recombinant human interleukin-2 (Proleukin, Chiron Therapeutics) will be administered as a five day (120 hr) continuous intravenous infusion at a dose of 18x106 IU per square meter of body surface area per day as per the Negrier regimen (21). The treatment schedule consists of two induction cycles and three maintenance cycles. Each induction cycle consists of two five-day courses of interleukin-2 infusion separated by a nine-day break. Each maintenance cycle consists of a five-day infusion followed by 23-day rest period of no therapy.; we will administer 1 X 107 DC cells. The autologous tumor cell vaccine (1 X 107 cells/1cc) in lactated ringers solution and injected into one (or two if clinically necessary) inguinal lymph nodes under ultrasound guidance. Each cycle of DC vaccine will be administered alternately in the right and left inguinal lymph nodes.; Recombinant human interferon alfa-2a (Roferon, Roche), at a dose of 6 million IU per day three times a week subcutaneously will be given during the two interleukin-2 induction cycles and during each interleukin-2 maintenance cycle
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Aldesleukin; Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent renal cell cancer; stage IV renal cell cancer

Summary:

      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).
    

Eligibility 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.