Esophageal Cancer, Gastric Cancer, Breast Cancer, Colorectal Cancer, Bladder Cancer, Biliary Tract Cancer
Conditions
Interventions
Injection of HER2 vaccine
Sponsors
International Cancer Laboratory Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must have histologically confirmed solid tumor 2. Women must not be pregnant 3. Doesn't have heart disease 4. Ability to understand and the willingness to sign a written informed consent document; the patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
Exclusion criteria
Exclusion criteria: 1. Patients with intracranial bleeding 2. Patients who have evidence of active infection that requires antibiotic therapy; patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment 3. Patients with known active human immunodeficiency virus (HIV), hepatitis A, hepatitis B, or hepatitis C infection 4. Patients with serious cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases 5. Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible 6. Splenectomized patients 7. Autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermatomyositis, or a vasculitic syndrome 8. Patients who have developed anaphylactic responses to other vaccines 9. History of congestive heart failure, coronary artery disease and myocardial infarction; active or unstable cardiovascular disease or cardiac disease requiring drug or device intervention 10. Patients on HER2 targeted therapies, such as Herceptin, Perjeta, Kadcyla, and Enhertu.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum HER2 concentration Tumor marker concentrations | — |
Countries
Japan
Contacts
Public ContactTakayoshi Ubuka
International Cancer Laboratory Co., Ltd. Division of Initiatives for Research and Development
Outcome results
None listed