Ex Vivo-Activated Lymph Node Lymphocytes in Treating Patients with Stage IIIC-IV Melanoma

Inclusion Criteria

• STEP 1
• Patients must have a histologic diagnosis of melanoma either from a primary or metastatic site; patients with brain metastases must have completed radiation therapy > 30 days prior to enrollment
• Patients must have American Joint Committee on Cancer (AJCC) stage IIIC unresected or IV disease
• Patients with non-measurable or measureable disease are eligible; measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter for non-nodal lesions and short axis for nodal lesions to be recorded) as >= 20 mm by chest x-ray, as >= 10 mm with computed tomography (CT) scan, or >= 10 mm with calipers by clinical exam; malignant lymph nodes, to be considered pathologically enlarged and measurable, must be >= 15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm); at baseline and in follow-up, only the short axis will be measured and followed * Tumor lesions that are situated in a previously irradiated area can be considered measurable as long as >= 30 days has passed since radiation to that area
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1
• Life expectancy (untreated) of > 4 months, in the opinion of and as documented by the investigator
• White blood count > 3,000/mcL
• Absolute neutrophil count > 1,200/mcL
• Platelet count > 100,000/mcL
• Serum creatinine < 2.0 mg/dL
• International normalization ratio (INR) =< 2.0 mg/dL
• In the opinion of the investigator, patient must be medically fit to undergo surgical procedure
• Patients treated with prior chemotherapy, cytotoxic chemotherapy, radiation, biotherapy, or any investigational agent > 30 days prior to lymph node removal are eligible
• Women of child-bearing potential must agree to use adequate contraception (double barrier method of birth control or abstinence) during participation in the study; should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately
• Patients must be disease free of prior invasive malignancies for > 5 years, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or cancer in-situ of the cervix
• Patients must be able to understand and willing to sign a written informed consent document
• STEP 2
• Successful removal of melanoma-draining lymph node (MDLN)
• Step 2: ECOG performance status =< 1
• Step 2: White blood count > 3,000/mcL
• Step 2: Absolute neutrophil count > 1,500/mcL
• Step 2: Serum creatinine < 2.0 mg/dL
• Serum direct bilirubin < 2 x institutional upper limit of normal
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal
• Patients with liver metastases who do not meet the eligibility parameters may only be enrolled at the discretion of the principal investigator (PI)

Exclusion Criteria

• Patients who are taking immunosuppressive medications that cannot be discontinued (corticosteroids); patients who have discontinued immunosuppressive medications but be at least 1 week post their last dose
• Patients for whom there is a plan to receive ipilimumab, vemurafenib, or other treatment for advanced melanoma
• Patients who are receiving any other investigational agents
• Patients with a history of autoimmune disease requiring continuous treatment
• Patients receiving any medications or substances to treat active infection
• Pregnant or breastfeeding
• Patients with human immunodeficiency virus (HIV) or hepatitis, or known active cytomegalovirus (CMV), Epstein–Barr virus (EBV) or any other viral illness requiring treatment are ineligible
• Any condition or behavior that in the judgment of the investigator, would compromise the patient’s ability to participate in the study and/or comply with study procedures
• Patients with bleeding disorders are ineligible due to lymph node removal possibly causing excessive bleeding; bleeding disorder will be defined by an INR level of > 2.0