Status:
COMPLETED
Safety and Efficacy of an Immune Response Modifier to Treat Inoperable Advanced Melanoma Skin Lesions
Lead Sponsor:
Pfizer
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Study 1501-852A is a Phase 1 Study with the objective of determining safety and the highest tolerated dose of an immune response modifier cream directly applied to advanced, inoperable, melanoma skin ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00091689
Start Date
September 1 2004
End Date
January 1 2006
Last Update
October 27 2008
Active Locations (2)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
2
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States