Adoptive Cell Therapy Following a Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Melanoma Patients

Inclusion Criteria

• •1. Measurable metastatic Melanoma with at least one lesion that is resectable for TIL generation.
• •2. Refractory to standard treatment
• •3. Patients with one or more brain metastases less than 1 cm each, and any patients with 1 or 2 brain metastases greater than 1 cm must have been treated and stable for 6 weeks.
• •4. Greater than or equal to 18 years of age.
• •5. Willing to practice birth control from the start of chemotherapy until 120 days after release from the hospital.
• •6. Clinical performance status of ECOG 0 or 1
• •7. Hematology:
• •Absolute neutrophil count greater than 1000/mm3 without support of filgrastim Normal WBC (greater than 3000/mm3). Hemoglobin greater than 8.0 g/dL Platelet count greater than 100,000/mm3
• •8. Serology:
• •Seronegative for HIV antibody. Seronegative for Hepatitis B or Hepatitis C.
• •9. Chemistry:
• •Serum ALT/AST less than three times the upper limit of normal (ULN). Serum creatinine less than or equal to 1.6 mg/dL Total bilirubin no more than 1.5 times the ULN, except in patients with Gilbert Syndrome who must have a total bilirubin less than 3 mg/dL.
• •10. Negative pregnancy test in women of child bearing potential because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
• •11. 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). Patients may have undergone minor surgical procedures with the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.