Safety study to determine highest dose of 90Y-hPAM4 can be safety administered
radiolabeled anti-MUC1 humanized antibody) administered intravenously as a single dose to patients with locally advanced and/or metastatic pancreatic cancer. The primary objective is to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of 90Y-hPAM4 in this population. Secondary objectives include the assessment of tumor targeting, biodistribution, organ dosimetry and pharmacokinetics (PK) of 90Y-hPAM4 as determined by pre-therapy administration of 111In-hPAM4, the assessment of the antigenicity of 90Y-hPAM4, as determined by development of human anti-humanized antibodies (HAHA), and to obtain preliminary information on the efficacy of single dose 90Y-hPAM4 in this patient population.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Single dose of 90Y-hPAM4 will be given and all patients will be followed for 12 weeks.
Goshen Cancer Center
Goshen, Indiana, United States
Nebraska Medical Center
Omaha, Nebraska, United States
University of Medicine and Dentistry
Newark, New Jersey, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
safety MTD
Time frame: over the first 12 weeks, then over 2 years
targeting, biodistribution, organ dosimetry
Time frame: first 2 weeks
pharmacokinetics (PK), antigenicity,
Time frame: first 12 weeks
efficacy
Time frame: over first 12 weeks, then over 2 years
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