Cyclophosphamide, Autologous Lymphocytes, and Aldesleukin in Treating Patients With Metastatic Melanoma

Inclusion Criteria

• Histopathological documentation of melanoma concurrent with the diagnosis of metastatic disease.
• 18 to 75 years of age and able to tolerate high-dose cyclophosphamide
• Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, CT scan).
• For patients receiving HD-IL-2, normal cardiac stress test within 182 days prior to enrollment is required of all patients over 50 years old or those with an abnormal ECG, any history of cardiac disease, a family history of cardiac disease, hypercholesterolemia or hypertension.

• For leukapheresis, patients must meet the following criteria (any exceptions to this will require prior approval by the Apheresis director and Principal Investigator):

  • Pulse: >45 or < 120
  • Weight: >45 kg
  • Temperature: <38C (<100.4 F)
  • WBC: >3,000
  • HCT: >30%
  • Platelets: >100,000
• ADDITIONAL INCLUSION CRITERIA FOR T CELL INFUSION

Exclusion Criteria

• Significant cardiovascular abnormalities as defined by any one of the following:

  • congestive heart failure,
  • clinically significant hypotension,
  • symptoms of coronary artery disease,
  • presence of cardiac arrhythmias on EKG requiring drug therapy
  • ejection fraction < 50 % (echocardiogram or MUGA)
• Patients with active infections or oral temperature > 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy.