An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Measurable Antibody Titer
Time frame: Up to Week 12
Overall Survival from date of randomization to death or end of study
Patients were scheduled to attend follow-up visits every four weeks after completion of the 12-week core period of the study and to continue until the patient was discharged from the study or declined further follow-up.
Time frame: Up to Last Patient Last Visit, January 2001
Injection Site Reaction
A physical examination for the presence of an abcess at the injection site was performed on each patient to assess tolerability to treatment at every posttreatment visit from Week 0 to Week 12.
Time frame: Through Week 12
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