Vaccine Therapy Plus Chemotherapy in Treating Patients With Metastatic or Locally Recurrent Stomach Cancer or Esophageal Cancer

Inclusion Criteria:

• Signed informed consent.
• Gastric adenocarcinoma, including adenocarcinoma of the esophagogastric junction, histologically proven.
• Measureable metastatic disease.
• Male or female subjects, age 18 years and older.
• Karnofsky performance status score equal to or greater than 70.
• Life expectancy of at least 3 months.
• Subjects must be chemotherapy naïve.
• At least 6 weeks from prior curative radiotherapy and 3 weeks from surgery.
• Adequate hematological and coagulation parameters: hemoglobin>9.5 g/dL; white blood cell count>3x10^9/L, platelets> 100x10^9/L; international normalized ratio of prothrombin time <1.2, and activated partial thromboplastin time no more than 5 seconds above normal limits.
• Adequate clinical chemistry parameters: creatinine<1.5mg/dL; total bilirubin<1.5mg/dL; and aspartate aminotransferase and alanine aminotransferase <2.5x upper normal levels.
• Able to comply with scheduled follow-up and with management of toxicity.
• Use contraceptive measures, if sexually active

Exclusion Criteria:

• Previous or current malignancies other than gastric adenocarcinoma, with the exception of adequately treated in situ carcinoma of the cervix, uteri, or nonmelanoma skin cancer
• Female subjects who are pregnant or nursing
• Female subjects with reproductive potential refusing a pregnancy test
• Any previous palliative chemotherapy, adjuvant or neoadjuvant chemotherapy, or investigational drug
• Any prior anticancer immunotherapy
• Immunodeficiency
• Bone marrow transplantation within 1 year
• Symptomatic peripheral neuropathy > Grade 2 NCI-CTC, Version 2.0 criteria
• Severe hearing disorder > Grade 2 NCI-CTC, Version 2.0 criteria
• Known dihydropyrimidine dehydrogenase deficiency
• Any other sever condition as defined by the following: unstable cardiac disease despite treatment; myocardial infarction within 6 months before study entry; history of significant neurologic or psychiatric disorders including dementia or seizures; active uncontrolled infection; active disseminated intravascular coagulation; or any other serious underlying medical conditions that could impair the ability of the subject to participate in the study
• Subjects who have previously demonstrated hypersensitivity to diphtheria toxoid
• Subjects who require chronic administration of corticosteroids
• Use in the past 30 days or concomitant use of immunosuppressants
• Use in the past 14 days or chronic concomitant use of proton pump inhibitors
• Subjects who have a history of hypercalcemia
• Subjects who cannot be regularly followed up for psychological, social, familial, or geographic reasons
• Subjects with expected noncompliance to toxicity management