A Pilot Study of the Administration of Young Tumor Infiltrating Lymphocytes Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen in Metastatic Melanoma

Inclusion Criteria

- INCLUSION CRITERIA:

- Measurable metastatic melanoma with available autologous TIL.

- Patients with 3 or less brain metastases are eligible. Note: If lesions are
symptomatic or greater than or equal to 1 cm each, these lesions must have been
treated and stable for 3 months for the patient to be eligible

- Greater than or equal to 18 years of age.

- 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 from the time of
enrollment on this study and for up to four months after receiving the preparative
regimen.

- 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 seronegative for hepatitis C antibody. If
hepatitis C antibody test is positive, then patient must be tested for the presence
of antigen by RT-PCR and be HCV RNA negative.

- Women of child-bearing potential must have a negative pregnancy test because of the
potentially dangerous effects of the preparative chemotherapy on the fetus.

- Hematology

- Absolute neutrophil count greater than 1000/mm(3) without the support of filgrastim

- WBC greater than or equal to 3000/mm(3)

- Platelet count greater than or equal to 100,000/mm(3)

- Hemoglobin > 8.0 g/dl

- Chemistry:

- Serum ALT/AST less than or equal to to 2.5 times the upper limit of normal

- Serum Creatinine less than or equal to to 1.6 mg/dl

- Total bilirubin less than or equal to 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).

Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as
long as all toxicities have recovered to grade 1 or less or as specified in the
eligibility criteria.

- Six weeks must have elapsed since any prior anti-CTLA4 antibody therapy to allow
antibody levels to decline.

- Patients must be ineligible to receive IL-2 based on evidence that may include
ischemic heart disease, or arrhythmias, or poor ventricular ejection fraction (<
50%), or respiratory compromise (FEV1 < 60%), or prolonged smoking history, or who
refuse the IL-2 portion of the ACT.

EXCLUSION CRITERIA:

- 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.

- 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.

- History of severe immediate hypersensitivity reaction to any of the agents used in
this study.

- Patients with a ventricular ejection fraction (less than or equal to 30%), or
respiratory compromise (FEV1 less than or equal to 40%).