Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer

Inclusion Criteria:

* Subjects with a histologically or cytologically confirmed diagnosis of pancreatic carcinoma, who were not eligible for tumor resection with curative intent (i.e., Stage II, III, or IV disease)
* Male or female subjects over 18 years of age
* Subjects with a life expectancy of at least 2 months
* KPS score of ≥60%
* Written informed consent

Exclusion Criteria:

* Previous, concomitant, or anticipated use (up to Week 12) of chemotherapy, radiotherapy, immunotherapy, or any other anticancer therapy
* Previous (during the 4 weeks before the study), concomitant, or anticipated use (up to Week 12) of immunosuppressants. However, for systemic \[i.e., oral or injected\] corticosteroids, previous use and concomitant use at study entry were prohibited, while introduction during the course of the study was permitted.)
* History of other malignant tumor within the previous 5 years, except nonmelanomatous skin cancer, and in situ carcinoma of the uterine cervix
* Known immunodeficiency
* Females who were pregnant, planning to become pregnant, or lactating (Women who, in the opinion of the investigator, were of childbearing potential were to have a negative pregnancy test before study drug administration.)
* Subjects taking part in another study involving an investigational or licensed drug or device in the 3 months preceding enrollment or up to Week 12 during this study
* Previous G17DT treatment
* Hematological indicators as follows:

  * Hemoglobin \<9.5 g/dL
  * Neutrophils \<2.0 × 109/L
  * Platelets \<100 × 109/L
* Any other condition or circumstance that might have the following results:

  * Worsen if the subject participated in the study
  * Reduce the subject's ability to comply with the protocol
  * Confound the interpretation of the study results