Safety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors

Exclusion Criteria

• •Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy within 4 weeks prior to the 1st dose of the study drug or those who have not recovered from adverse events from agents administered more than 4 weeks earlier.
• •Use of investigational agent in the 4 weeks prior to 1st dose of the study drug
• •Use of immunosuppressive therapy in the 4 weeks prior to the 1st dose
• •Have a history of, or clinical evidence of, myocardial ischemia, congestive heart failure, or myocardial arrhythmias requiring treatment within the past 6 months
• •Have uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, immune dysfunction such as autoimmune disease, endocrine dysfunction such as hypo- or hyperthyroidism, psychiatric illness such as depression or suicidal tendency or social situations that would limit compliance with study requirements
• •Have a history of disease requiring ongoing steroid treatment
• •Have a history of seizure disorders uncontrolled on medication
• •Have a history of clinically significant coagulation or bleeding disorders or abnormalities
• •Are HIV positive. HIV positive subjects are excluded from the study because of possible interactions with the immunomodulatory effects of 852A and because of potential pharmacokinetic interactions associated with combination retroviral therapy.
• •Are pregnant or lactating