Chemotherapy Followed by ESO-1 Lymphocytes and Aldesleukin to Treat Metastatic Cancer

• INCLUSION CRITERIA:
• Metastatic cancer that expresses ESO as assessed by one of the following methods: RT-PCR on tumor tissue, or by immunohistochemistry of resected tissue, or serum antibody reactive with ESO. Metastatic cancer diagnosis will be confirmed by the Laboratory of Pathology at the NCI.
• Patients with histologies other than metastatic melanoma, must have previously received systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred.
• Greater than or equal to 18 years of age.
• Willing to sign a durable power of attorney.
• Able to understand and sign the Informed Consent Document.
• Clinical performance status of ECOG 0 or 1.
• Life expectancy of greater than three months.
• Patients of both genders must be willing to practice birth control for four months after receiving the preparative regimen.
• Patients must be HLA-A*0201 positive

• Serology:

  • Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune -competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)
  • Seronegative for hepatitis B antigen and hepatitis C antibody unless antigen negative.

• Hematology:

  • Absolute neutrophil count greater than 1000/mm(3) without the support of filgrastim.
  • WBC (greater than 3000/mm(3)).
  • Platelet count greater than 100,000/mm(3).
  • Hemoglobin greater than 8.0 g/dl.

• Chemistry:

  • Serum ALT/AST less or equal to 2.5 times the upper limit of normal.
  • Serum creatinine less than or equal to 1.6 mg/dl.
  • Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
• More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).
• Six weeks must have elapsed since prior MDX-010 therapy to allow antibody levels to decline.
• Patients who have previously received MDX-010 or ticilimumab must have a normal colonoscopy with normal colonic biopsies.

EXCLUSION CRITERIA:

• Prior vaccination with an ALVAC containing vaccine for patients who will receive the ALVAC ESO-1 vaccine (cohorts 3 or 4).
• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
• Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
• Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
• Concurrent Systemic steroid therapy.
• Known systemic hypersensitivity to any of the vaccine components, including egg products or Neomycin for patients who will receive the ALVAC ESO-1 vaccine (cohorts 3 or 4).
• History of severe immediate hypersensitivity reaction to any of the agents used in this study.
• History of coronary revascularization or ischemic symptoms.
• Any patient known to have an LVEF less than or equal to 45 percent.

• Documented LVEF of less than or equal to 45 percent tested in patients with:

  • History of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block.
  • Age greater than or equal to 60 years old.

• Documented FEV1 less than or equal to 60 percent predicted tested in patients with:

  • A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2 years).
  • Symptoms of respiratory dysfunction