This is a study to test whether different doses of 90Y-hPAM4 are safe to give in combination with gemcitabine in patients with previously untreated pancreatic cancer.
Patients receive a 4-week treatment cycle with once-weekly 30-minute gemcitabine infusions beginning one week prior to the first 90Y-hPAM4dose and continuing during the 3 consecutive weeks over which once weekly 90Y-hPAM4 doses are given. Depending on toxicity, patient cohorts will receive one of several possible 90Y and gemcitabine dose combinations. Post-treatment evaluations conducted until instituting another 90YhPAM4 treatment cycle, maintenance gemcitabine or for a maximum period of 12 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
90Y-hPAM4 once weekly for 3 weeks gemcitabine once weekly for 4 weeks
Christiana Care Health Services
Newark, Delaware, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Herbert Werthem College of Medicine/Jackson North Medical Center
Miami, Florida, United States
safety will be evaluated based upon physical examinations, hematology and chemistry laboratory testing as well as toxicity
Time frame: over 12 weeks
Efficacy and Clinical benefit measures such as quality of life, pain assessments, etc.
Time frame: over 5 years
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Moffit Cancer Center
Tampa, Florida, United States
Winship Cancer Institute/Emory University Hospital
Atlanta, Georgia, United States
Goshen Cancer Center
Goshen, Indiana, United States
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
Mt. Sinai Medical Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
...and 1 more locations