TURNSTILE I - SCREENING:
TURNSTILE II - TREATMENT:
TURNSTILE I - SCREENING
TURNSTILE II - TREATMENT
Patients must have a lesion amenable to resection for the generation of TIL (Turnstile I)
Patients receiving cytotoxic agents will be evaluated by the PI or his designee for eligibility suitability (Turnstile I)
Patients must have adequate TIL available (Turnstile II); pre-rapid expansion procedure (Pre-REP) TIL generated in the similar clinical trial 2004-0069 may also be utilized for Turnstile II
Patients must have at least one biopsiable measurable metastatic melanoma, lesion > or = to 1 cm (Turnstile II)
Patients may have brain lesions =< 1 cm each; the PI or designee will approve the treatment (Turnstile II)
Clinical performance status of ECOG 0-2 within 30 days of signing informed consent (Turnstile II)
Hemoglobin greater than or equal to 8.0 g/dl (Turnstile II)
Serum creatinine less than or equal to 1.6 mg/dl (Turnstile II)
MRI/CT/PET of the brain within 30 days of lymphodepletion (Turnstile II)
Patients who are pregnant or nursing (Turnstile I)
Women who are pregnant will be excluded (Turnstile II)
TURNSTILE I INCLUSION CRITERIA:
Patients must have a lesion amenable to resection for the generation of TIL (Turnstile I)
Patients must have adequate TIL available (Turnstile II)
Patients must have at least one biopsiable and measurable metastatic melanoma lesions >= 1 cm (Turnstile II)
Patients may have brain lesions which measure =< 1 cm each (Turnstile II)
Pregnancy testing will be performed within 14 days prior to treatment (Turnstile II)
Clinical performance status of ECOG 0-2 within 14 days of lymphodepletion (Turnstile II)
Hemoglobin greater than or equal to 8.0 g/dl (Turnstile II)
Serum creatinine less than or equal to 1.6 mg/dl (Turnstile II)
Patients who are pregnant or nursing (Turnstile I)
Has had prior systemic cancer therapy within the past four weeks at the time of the start of the lymphodepletion regimen (Turnstile II)
Women who are pregnant will be excluded (Turnstile II)
Patients must be HLA-A2 for cohort A (Turnstile II-Chemotherapy/Cell Infusion-Inclusion Criteria)
Patients must have adequate TIL available (Turnstile II)
Patients must have measurable metastatic melanoma (Turnstile II - Chemotherapy/Cell Infusion -Inclusion Criteria)
Pregnancy testing will be performed within 7 days prior to treatment (Turnstile II)
Clinical performance status of ECOG 0 - 2 at the time of chemotherapy infusion (Turnstile II - Chemotherapy/Cell Infusion - Inclusion Criteria)
Absolute neutrophil count greater than or equal to 750/mm^3 (Turnstile II - Chemotherapy/Cell\r\nInfusion- Inclusion Criteria)
Platelet count greater than or equal to 75,000/mm^3 (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria)
Hemoglobin greater than or equal to 8.0 g/dl (Turnstile II - Chemotherapy/Cell Infusion)
Serum alanine aminotransferase (ALT) less than three times the upper limit of normal (Turnstile II - Chemotherapy/Cell Infusion- Inclusion Criteria)
Serum creatinine less than or equal to 1.6 mg/dl (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria)
Is not receiving B-RAF treatment (Cohort C) (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)
Women who are pregnant or nursing will be excluded (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)
{Turnstile
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(Turnstile 1 & Turnstile 2) Willing and able to give informed consent.