| Inclusion Criteria: | 1) Patients must have metastatic melanoma or stage III in-transit or regional nodal disease. (Turnstile I)
2) Patients must receive an MRI/CT of the brain or PET/CT. If new lesions are present, PI or his designee should make final determination regarding enrollment. (Turnstile I)
3) Age greater than or equal to 12 years. (Turnstile I)
4) Clinical performance status of ECOG 0-2. (Turnstile I)
5) Patients previously treated with immunotherapy, targeted therapy, or no therapy will be eligible. Patients receiving cytotoxic agents will be evaluated by the PI or his designee as to suitable eligibility. (Turnstile I)
6) Patients with a negative pregnancy test (urine or serum) must be documented at screening for women of childbearing potential. (Turnstile I)
7) Patients must be HLA-A2 for cohort A. (Turnstile II-Chemotherapy/Cell Infusion-Inclusion Criteria)
8) Patients must have adequate TIL available. (Turnstile II)
9) Patients must have measurable metastatic melanoma. (Turnstile II - Chemotherapy/Cell Infusion -Inclusion Criteria).
10) Patients may have brain lesions which measure </= 1cm each. Lesions that are >1 cm that have been treated with SRS and in the opinion of the PI or his designee no longer represents active disease will also be allowed.(Turnstile II - Chemotherapy/Cell Infusion- Inclusion Criteria).
11) Patients of both genders must practice birth control for four months after receiving the preparative regimen. Patients must have a documented negative pregnancy test (urine or serum) for women who have menstruation in the past 12 months and without sterilization surgery. (Turnstile II)
12) Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the patient agrees to continue to use a barrier method of contraception throughout the study such as: condom, diaphragm, hormonal, IUD, or sponge plus spermicide. Abstinence is an acceptable form of birth control. (Turnstile II)
13) Clinical performance status of ECOG 0 - 2 at the time of chemotherapy infusion. (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria).
14) Absolute neutrophil count greater than or equal to 1000/mm3. (Turnstile II - Chemotherapy/Cell Infusion- Inclusion Criteria).
15) Platelet count greater than or equal to 100,000/mm3. (Turnstile II - Chemotherapy/Cell Infusion- Inclusion Criteria).
16) Hemoglobin greater than or equal to 8.0 g/dl. (Turnstile II - Chemotherapy/Cell Infusion).
17) Serum ALT less than three times the upper limit of normal. (Turnstile II - Chemotherapy/Cell Infusion- Inclusion Criteria).
18) Serum creatinine less than or equal to 1.6 mg/dl. (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria).
19) Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. (Turnstile II - Chemotherapy/Cell Infusion - Inclusion Criteria).
20) Patients randomized to receive the DC arm of Cohort A will have the following tests: Donor infectious disease panel must be performed which includes the following tests: Hepatitis B surface antigen (HBsAg), Anti-Hepatitis B core antibody (HBC Abs),Anti-Hepatitis C Virus antibody (HCV Ab), Anti-Human Immunodeficiency Virus (HIV) antibody (HIV ½ Ab), Anti-Human T cell lymphotrophic Virus (HTLV) antibody (HTLV I/II Ab), Rapid Plasma Reagen (RPR), Cytomegalovirus antibody (CMV), HCV/HIV Nucleic Acid Test, West Nile Virus Nucleic Acid Test, Chagas Disease, and Sickledex.
21) A stress cardiac test (stress thallium, stress MUGA, dobutamine echocardiagram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion. (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria).
22) Pulmonary function tests (FEV1>65% or FVC>65%of predicted) within 6 months of lymphodepletion. (Turnstile II - Chemotherapy/Cell Infusion - Inclusion Criteria).
23) MRI/CT of brain or PET/CT (Turnstile II-Chemotherapy/Cell Infusion-Inclusion Criteria) |