Status:
COMPLETED
Safety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
Pfizer
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00095160
Start Date
October 1 2003
End Date
January 1 2006
Last Update
November 29 2017
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455