TNF-Bound Colloidal Gold in Treating Patients With Advanced Solid Tumors

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed solid tumor
• •Advanced and/or metastatic disease
• •Unresponsive to conventional therapy (i.e., disease progressed while receiving any known standard curative or palliative therapy) OR previously untreated tumor for which no standard treatment exists
• •Measurable or evaluable metastatic disease
• •No lymphoma or other hematologic malignancy
• •No known brain metastases
• •* Previously treated brain metastases with no evidence of recurrence allowed
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •Life expectancy ≥ 3 months
• •Absolute neutrophil count ≥ 1,500/mm³
• •Platelet count ≥ 100,000/mm³
• •Creatinine ≤ 2.0 mg/dL
• •Bilirubin ≤ 2.5 mg/dL
• •ALT and AST ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present)
• •Alkaline phosphatase ≤ 1.5 times ULN (3 times ULN if liver metastases are present)
• •Prothrombin time ≤ 1.5 times ULN
• •Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
• •LVEF ≥ 45% by echocardiogram or thallium stress test for patients \> 50 years of age or history of cardiovascular disease
• •FEV\_1 and DLCO \> 30% of predicted for patients with a history of pulmonary disease
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No active bacterial or viral infection with systemic manifestations (e.g., fever, symptoms, leukocytosis)
• •* Localized chronic infections, such as mild acne or tinea pedis allowed
• •No acute or chronic viral hepatitis
• •No known bleeding disorder
• •No other concurrent life-threatening illness, including any of the following:
• •* Unstable angina
• •* Severe oxygen-dependent chronic obstructive pulmonary disease
• •* End-stage liver disease
• •No known active renal disease or renal insufficiency as evidenced by serum creatinine \> 2.0 mg/dL
• •No HIV positivity
• •PRIOR CONCURRENT THERAPY:
• •Recovered from prior therapy
• •More than 3 weeks since prior biological or cytotoxic agents (6 weeks for nitrosoureas)
• •No known requirment for palliative treatment
• •No concurrent surgery
• •No other concurrent anticancer therapy