Safety and Efficacy of an Immune Response Modifier to Treat Inoperable Advanced Melanoma Skin Lesions
Melanoma

About this trial
This is an interventional treatment trial for Melanoma focused on measuring Advanced Metastatic Melanoma
Eligibility Criteria
Inclusion Criteria: Have melanoma cutaneous metastasis or lentigo maligna melanoma unresectable and for which standard curative or palliative measures do not exist or are no longer effective. 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 Exclusion Criteria: Need for non-steroidal anti-inflammatory drugs (NSAIDs) during the study Have a body mass index (BMI)> 30 kg/m2 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 disorder (other than febrile seizures in childhood) 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.
Sites / Locations
- Dartmouth-Hitchcock Medical Center
- Oklahoma Medical Research Foundation