Safety and Efficacy of Combination HDI and Anti-CTLA4 for Recurrent Inoperable Stage III or Stage IV Melanoma

Inclusion Criteria

• Patients must have a written informed consent obtained prior to the initiation of study procedures.
• Male and female subjects greater than or equal to 18 years of age.
• Patients must have histologically confirmed recurrent stage III or stage IV melanoma (AJCC 6th edition classification). Cutaneous melanoma, ocular or mucosal melanoma will be eligible.
• Patients must have measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Baseline measurements must be obtained within 4 weeks prior to initiating therapy.
• Patients must have adequate hematologic, renal, and liver function as evidenced by the following (within 4 weeks prior to starting the study drugs):
• WBC greater than or equal to 3,000/mm3
• Lymphocytes greater than or equal to 1,000/mm3
• Platelets greater than or equal to 100,000/mm3
• Serum Creatinine less than or equal to 1.5 x upper limit of normal (ULN)
• Serum Bilirubin less than or equal to 1.5 x ULN
• Serum AST/ALT less than or equal to 2.5 x ULN
• Serum LDH less than or equal to 2.0 x ULN
• APTT less than 38.1°C).
• Treatment with anticoagulants, except to keep an indwelling line patent.
• Systemic steroid or other immunosuppressive therapy within 4 weeks of starting the study.
• Treatment with any investigational product within 28 days of registration.
• History of inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any origin, or any history of diverticulitis (even a single episode) or evidence of diverticulitis at baseline, including evidence limited to CT-scan only.
• Patients who did not tolerate high-dose interferon-α therapy in the adjuvant setting will be excluded.