The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.
Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with G17DT either immediately (Group A), or following biliary stenting when jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A booster injection was offered to patients who had measurable anit-G17Dt antibodies but had anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were evaluated until study closure ort until patient death.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Pharmacodynamic
Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit.
Time frame: Weeks 0, 1,3,4,6,8,12, 16+
Patient Survival
The vital status of patients was monitored throughout the study and was followed until death or the end of the study.
Time frame: Up to week 139
Injection Tolerability
Tolerability was assessed by injection site during first 16 weeks after the first injection.
Time frame: Up to Week 16
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