Study 1493-852A is a phase 1 study with the primary objective of determining safety and the
highest tolerated dose of an experimental immune response modifier administered intravenously
to patients with solid organ tumors not responsive to currently available treatments. The
secondary objective of the study is to monitor the tumor response to this form of treatment.
- Have solid organ tumors refractory to currently available treatments.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Have a life expectancy of 4 months
- Have normal organ and bone marrow function
- 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
- 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