Phase Ib/II study of ALT-801 with cisplatin in patients with metastatic melanoma

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

ENTRY CRITERIA: DISEASE CHARACTERISTICS: * Locally advanced or metastatic melanoma * Measurable * Histologically or cytologically confirmed * Surgically incurable * HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT THERAPY: * If prior Proleukin treatment, must have had clinical benefit * No prior systemic cytotoxic chemotherapy for melanoma * No concurrent radiotherapy, chemotherapy, or other immunotherapy * More than 4 weeks since prior major radiotherapy * More than 8 weeks since prior CTLA-4 antagonist immunotherapy * Not receiving other investigational agents PATIENT CHARACTERISTICS: Life expectancy * \> 3 months Performance status * ECOG 0 or 1 Bone marrow reserve * Absolute neutrophil count (AGC/ANC) ≥ 1,500/uL * Platelets ≥100,000/uL * Hemoglobin ≥ 10g/dL Renal function * Serum creatinine ≤ 1.5 mg/dL Hepatic function * Total bilirubin ≤ 1.5 X ULN * AST ≤ 2.5 X ULN * Alkaline phosphatase ≤ 2.5 X ULN * PT INR ≤ 1.5 X ULN * aPTT ≤ 1.5 X ULN Cardiovascular * May be safely tapered off anti-hypertensives if currently on anti-hypertensives * New York Heart Association classification I or II * No congestive heart failure \<6 months * No unstable angina pectoris \<6 months * No myocardial infarction \<6 months * No history of ventricular arrhythmias * Normal cardiac stress test required if any of the following is present: * Age ≥ 50 * History of abnormal EKG * Symptoms of cardiac ischemia or arrhythmia Pulmonary * Normal pulmonary function test (FEV1 ≥ 70% of predicted value) if any of the following is present: * Prolonged history of cigarette smoking * Symptoms of respiratory dysfunction Other * No known autoimmune disease * No known HIV positive * No psychiatric illness/social situations that would limit study compliance * No history or evidence of CNS disease * No active systemic infection requiring parental antibiotic therapy * No systemic steroid therapy required * No prior organ allograft or allogeneic transplantation * Not receiving chronic medication for asthma * Not pregnant or nursing * Fertile patients must use effective contraception