CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma

Inclusion Criteria

• ELIGIBILITY FOR ENROLLMENT
• Histopathologic documentation of melanoma concurrent with the diagnosis of metastatic disease
• Expression of human leukocyte antigen (HLA)-A2
• Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of '0-1' at screening visit
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized; suggested precautions should be used to minimize the risk of pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion, and at least 8 weeks after the study drug is stopped; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal
• Men must be willing and able to use an acceptable method of birth control, for at least 3 months after completion of the study, if their sexual partners are WOCBP
• Willing and able to give informed consent
• Adequate venous access - consider peripherally inserted central catheter (PICC) or central line
• Evaluation of v-raf murine sarcoma viral oncogene homolog B (BRAF)V600 mutation status
• Measurable tumor (by Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
• Melan-A (MART) 1 or solute carrier family 45, member 2 (SLC45A2) (+) staining results; (if patients have not had staining test in the past, the test will be run after patient consent is obtained, but before enrollment)
• ELIGIBILITY FOR TREATMENT (INCLUDES CYCLOPHOSPHAMIDE, T CELL, ANTI-CTLA4 INFUSIONS AND SC IL-2)
• ECOG/Zubrod performance status of '0-1'
• At least 4 weeks must have elapsed since the last chemotherapy, radiotherapy or major surgery; at least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin; if started before T-cell administration, ipilimumab infusions must be least 21 days apart
• Toxicity related to prior therapy must either have returned to = = 3.0 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >= 2.5 x ULN
• Bilirubin >= 3 x ULN
• Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy
• Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose
• Patients may not be on any other treatments for their cancer aside from those included in the protocol; patients may not undergo another form of treatment concurrently with this study
• EXCLUSION CRITERIA FOR TREATMENT
• WBC = = 3.0 x ULN (prior to cyclophosphamide and T cell infusions)
• AST/ALT >= 2.5 x ULN (prior to cyclophosphamide and T cell infusions)
• Bilirubin >= 3 x ULN (prior to cyclophosphamide and T cell infusions)
• Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception; women of childbearing potential with a positive pregnancy test within 3 days prior to entry.
• Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy.
• Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose.
• Patients may not be on any other treatments for their cancer aside from those included in the protocol. Patients may not undergo another form of treatment concurrently with this study.
• Active and untreated central nervous system (CNS) metastasis (including metastasis identified during screening MRI or contrast CT):
• No signs or symptoms of CNS mets within the last 30 days (from enrollment evaluation).
• No single lesion larger than 1cm
• No more than 5 lesions