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

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy and chemotherapy in treating patients who have metastatic or locally recurrent stomach cancer or esophageal cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Fluorouracil

Criteria

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