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

Inclusion Criteria

• •STEP 1
• •* Participants must have a histologic diagnosis of melanoma either from a primary or metastatic site; Participants with brain metastases must have completed radiation therapy \>30 days prior to enrollment
• •* Participants must have American Joint Committee on Cancer (AJCC) stage IIIC unresected or IV disease
• •* Patients with non-measureable or measurable 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 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 normalized ratio (INR) ≤ 2.0
• •* In the opinion of the investigator, participant must be medically fit to undergo surgical procedure
• •* Participants 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
• •* Participants 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
• •* Participants must be able to understand and willing to sign a written informed consent document
• •STEP 2
• •* Successful removal of melanoma-draining lymph node (MDLN)
• •* ECOG Performance status ≤ 1
• •* White blood count \> 3,000/mcL
• •* Absolute neutrophil count \> 1,500/mcL
• •* Platelet count \> 100,000/mcL
• •* 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 glutamic pyruvate transaminase \[SGPT\]) \< 2.5 X institutional upper limit of normal
• •* Participants with liver metastases who do not meet the eligibility parameters may only be enrolled at the discretion of the principal investigator (PI)