QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma

This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 combined with cisplatin. The purpose of this study is to evaluate the safety, determine the Maximum-Tolerated Dose (MTD), and characterize the pharmacokinetic profile of ALT-801 given with cisplatin in patients who are chemotherapy naïve and have metastatic melanoma that is considered surgically incurable. The anti-tumor responses of ALT-801 with cisplatin will also be assessed in this trial.

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 \