Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies

ENTRY CRITERIA:

DISEASE CHARACTERISTICS:

• Locally advanced or metastatic malignancies
• Histologically or cytologically confirmed
• Evaluable
• Surgically and medically incurable
• Not responding to standard therapy or no other standard therapy exists
• Human leukocyte antigen (HLA)-A2.1/p53 positive

PRIOR/CONCURRENT THERAPY:

• No prior Proleukin therapy within one year
• No concurrent radiotherapy, chemotherapy, or other immunotherapy
• More than 4 weeks since prior major radiotherapy
• More than 4 weeks since prior cytotoxic therapy
• More than 6 weeks since prior nitrosoureas therapy
• More than 8 weeks since prior monoclonal antibody therapy

PATIENT CHARACTERISTICS:

Life expectancy

• > 3 months

Performance status

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Bone marrow reserve

• Absolute neutrophil count (AGC/ANC) ≥ 1, 500/microliters (uL)
• Platelets ≥100,000/uL
• Hemoglobin ≥ 10g/dL

Renal function

• Serum creatinine ≤ 1.5 X Upper limit of normal (ULN)

Hepatic function

• Total bilirubin ≤ 1.5 X ULN
• Aspartate Aminotransferase (AST) ≤ 2.5 X ULN
• Alkaline phosphatase ≤ 2.5 X ULN
• Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 X ULN
• Activated partial thromboplastin time (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:
• Over age 50
• History of abnormal EKG
• Symptoms of cardiac ischemia or arrhythmia

Pulmonary

• Normal pulmonary function test (FEV1 ≥ 75% 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 central nervous system (CNS) disease
• No active systemic infection requiring parental antibiotic therapy
• No systemic steroid therapy required
• No prior organ allograft
• Not receiving other investigational agents
• Not receiving chronic medication for asthma
• Not pregnant or nursing
• Fertile patients must use effective contraception