Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer, recurrent melanoma, stage IV melanoma, unspecified adult solid tumor, protocol specific Read More

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic cancer

• Tumor overexpresses p53 as assessed by immunohistochemistry (i.e., ≥ 5% tumor cells stain positive for p53)

  • Biopsy must be available to evaluate p53 expression
• Human leukocyte antigens 0201 (HLA-A*0201) positive

• Progressive or recurrent disease after prior standard therapy for metastatic disease

  • Patients with melanoma or renal cell cancer must have previously received aldesleukin
  • Patients with other histologies, not including hematologic malignancies, must have previously received first-line and second-line or higher systemic standard therapy (or effective salvage chemotherapy regimens)

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Life expectancy > 3 months
• Absolute neutrophil count > 1,000/mm^3
• White blood cell (WBC) > 3,000/mm^3
• Platelet count > 100,000/mm^3
• Hemoglobin > 8.0 g/dL
• Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal
• Serum creatinine ≤ 1.6 mg/dL
• Total bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL in patients with Gilbert's syndrome)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 4 months after completion of study treatment
• Patients who have previously received ipilimumab or ticilimumab must have a normal colonoscopy with normal colonic biopsies
• Human immunodeficiency virus (HIV) antibody negative
• Hepatitis B antigen and hepatitis C antibody negative (unless antigen negative)
• No primary immunodeficiency (e.g., severe combined immunodeficiency disease)
• No active systemic infections
• No history of severe immediate hypersensitivity reaction to any of the agents used in this study
• No coagulation disorders
• No myocardial infarction or cardiac arrhythmias
• No history of coronary revascularization
• No obstructive or restrictive pulmonary disease
• No contraindications for high-dose aldesleukin administration

• Left ventricular ejection fraction (LVEF) ≥ 45% in patients meeting any of the following criteria:

  • History of ischemic heart disease,
  • chest pain,
  • or clinically significant atrial and/or ventricular arrhythmias including, but not limited to, atrial fibrillation,
  • ventricular tachycardia,
  • or second- or third-degree heart block
  • At least 60 years of age

• Forced expiratory volume 1 (FEV_1) > 60% predicted in patients meeting any of the following criteria:

  • Prolonged history of cigarette smoking (> 20 pack/year within the past 2 years)
  • Symptoms of respiratory dysfunction

• No other major medical illness of the cardiovascular,

  • respiratory,
  • or immune system

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from prior therapy
• More than 4 weeks since prior and no concurrent systemic steroid therapy
• More than 4 weeks since other prior systemic therapy
• More than 6 weeks since prior ipilimumab