1. Measurable metastatic Melanoma with at least one lesion that is resectable for TIL
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
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
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
Seronegative for HIV antibody. Seronegative for Hepatitis B or Hepatitis C.
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.
1. Women of child-bearing potential who are pregnant or breastfeeding because of the
potentially dangerous effects of the non-myeloablative, lymphodepleting induction
regimen on the fetus or infant.
2. Systemic steroid therapy required.
3. Active systemic infections, coagulation disorders or other active major medical
illnesses of the cardiovascular, respiratory or immune system, as evidenced by a
positive stress thallium or comparable test, myocardial infarction, cardiac
arrhythmias, obstructive or restrictive pulmonary disease.
4. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease
5. 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
6. History of severe immediate hypersensitivity reaction to any of the agents used in
this study , including history of an anaphylactic reaction to penicillin or gentamicin
7. History of coronary revascularization or ischemic symptoms
8. Any patient known to have an LVEF less than or equal to 50 percent .
9. Documented LVEF of less than or equal to 50 percent tested in patients with clinically
significant atrial and/or ventricular arrhythmias including but not limited to: atrial
fibrillation, ventricular tachycardia, second or third degree heart block
10. Documented FEV1 and DLCO (relative to predicted) less than or equal to 60 percent