Tumor-Infiltrating Lymphocytes After Combination Chemotherapy in Treating Patients With Metastatic Melanoma

Exclusion Criteria

• •Men or women of reproductive ability who are unwilling to use effective contraception or abstinence for 4 months after treatment
• •Calculated creatinine clearance (estimated glomerular filtration rate \[eGFR\]) \< 60 ml/min; EGFR values can be determined by either Modification of Diet in Renal Disease (MDRD) or Cockcroft-Gault equation based on the investigator's discretion
• •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 3 x upper limit of normal
• •Total bilirubin \> 2.0 mg/dl, except in patients with Gilbert's syndrome whose total bilirubin must not exceed 3.0 mg/dl) deemed by investigator to be irreversible
• •FEV1 \< 65% predicted, FVC \< 65% of predicted, DLCO (corrected for hemoglobin \[Hgb\]) \< 50% predicted); pulmonary function tests (PFTs) within 4 months prior to consent for Step I will be required for patients with underlying risk factors such as smoking history \> 10 pack years, or a history of pre-existing symptomatic lung disease (not including melanoma metastases to the lung)
• •Pre-existing known cardiovascular abnormalities as defined by any one of the following:
• •* Congestive heart failure
• •* Clinically significant hypotension
• •* Cardiac ischemia, or symptoms of coronary artery disease
• •* Presence of cardiac arrhythmias on electrocardiogram (EKG) requiring drug therapy
• •* Ejection fraction \< 45% (echocardiogram or MUGA), although any patient with an ejection fraction between 45-49% must receive clearance by a cardiologist to be eligible for Step II of the trial
• •Patients with active systemic infection requiring intravenous antibiotics
• •Clinically significant psychiatric disease which, in the opinion of the PI or sub-investigator (I), would render immunotherapy and its potential sequelae unsafe or compliance with procedural requirements unlikely
• •Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within 14 days prior to entry; patients of both genders must practice birth control during treatment and for four months after treatment
• •Calculated creatinine clearance (eGFR) \< 60 ml/min; EGFR values can be determined by either MDRD or Cockcroft-Gault equation based on the investigator's discretion
• •AST/ALT \> 3 x upper limit of normal
• •Total bilirubin \> 2.0 mg/dl, except in patients with Gilbert's syndrome whose total bilirubin must not exceed 3.0 mg/dl)
• •Clinically significant pulmonary dysfunction (FEV1 \< 65% predicted or FVC \< 65% of predicted, DLCO (corrected for Hgb) \< 50% predicted)
• •Pre-existing known cardiovascular abnormalities as defined by any one of the following:
• •* Congestive heart failure
• •* Clinically significant hypotension
• •* Cardiac ischemia, or symptoms of coronary artery disease
• •* Presence of cardiac arrhythmias on EKG requiring drug therapy
• •* Ejection fraction \< 45%, although any patient with an ejection fraction between 45-49% must receive clearance by a cardiologist to be eligible for Step II of this trial
• •Absolute neutrophil count less than 1000/mm\^3
• •Platelet count less than 100,000/mm\^3
• •Hemoglobin less than 10.0 g/dl
• •Untreated central nervous system metastases that are either symptomatic or greater than 1 cm at time of therapy; lesions that are \> 1cm that have been irradiated and in the opinion of the PI or sub-I no longer represent active disease may be allowed
• •Patients with systemic infections requiring active therapy within 72 hours of lymphodepletion
• •Systemic cancer therapy (standard or experimental), including cytotoxic chemotherapy or IL-2, received less than 4 weeks or checkpoint blocking agents (e.g., cytotoxic T-lymphocyte protein \[CTLA\]-4 or programmed cell death protein \[PD\]1/PD-ligand \[L\]1 inhibitors) received less than 6 weeks prior to lymphodepletion, with the exception of targeted therapies
• •Commercially available, molecularly targeted therapies (e.g., dabrafenib, trametinib, vemurafenib, imatinib) taken within 7 days prior to lymphodepletion
• •Prior treatment with systemic steroids within 4 weeks prior to lymphodepletion (except for physiologic replacement doses for adrenal insufficiency, premedication for contrast allergies for scans, and for drug fever related to targeted therapy)
• •Any other significant medical or psychological conditions that would make the patient unsuitable candidate for cell therapy at the discretion of the PI