Randomized Clinical Trial Evaluating the Use of the Laser-Assisted Immunotherapy (LIT/inCVAX) in Advanced Breast Cancer

Exclusion Criteria

• •1. Patient has received prior treatment with glycated chitosan or laser-assisted immunotherapy GC Injection.
• •2. Patient has a known allergic reaction to shellfish, crabs, crustaceans, or any study components used in treatment.
• •3. Patient has symptomatic or untreated CNS disease, including seizures. Patients with asymptomatic CNS metastases are eligible provided that they have been clinically stable for a minimum of 4 weeks and are not on steroid treatment.
• •4. Patient has impaired cardiac function of clinical significance or has experienced within 6 months of initiation of treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
• •5. Patient has an implantable pacemaker or cardioverted defibrillator within 5 cm of the laser-accessible solid tumor to be treated with laser-assisted immunotherapy.
• •6. Patient has uncontrolled hypertension.
• •7. Patient has an ongoing requirement for therapeutic anticoagulation therapy (low-dose anticoagulants or low molecular weight heparin for the prevention of deep vein thrombosis and maintenance of patency of central venous devices is allowed)
• •8. Patient has HIV or AIDS or history of chronic hepatitis B or C (those who are considered cured of chronic hepatitis B or C may be allowed). Physician may test the patient for hepatitis and exclude the patient if the test is positive.
• •9. Patient has a serious autoimmune disease (e.g., Lupus). Consultation with medical monitor is required to discuss enrollment if patient has autoimmune disease.
• •10. Patient has an active infection requiring antibiotics.
• •11. Patient has presence of ascites or pleural effusion requiring chronic medical intervention.
• •12. Patient is receiving concomitant treatment with systemic corticosteroids (e.g., predisone) or other immunosuppressive therapy (e.g., methotrexate). Patient should be free of corticosteroid use for at least 18 weeks prior to trial enrollment
• •13. Patient has received treatment with chemotherapy, radiation, hormones, antibody or other immunotherapy, gene therapy, vaccine therapy, or an investigational product like a treatment for cancer within 4 weeks prior to the start of the study treatment or within 5 t1/2 of a drug, whichever is shorter.
• •14. Patient has unresolved toxicities from prior anticancer therapy that may limit the ability to remain in the study.
• •15. Patient has had a surgical procedure ≤14 days prior to the first scheduled treatment; in all cases, the patient must be sufficiently recovered and stable before treatment administration.
• •16. Patient has any serious or unstable concomitant systemic conditions that are incompatible with this clinical study (e.g., substance addiction, psychiatric disturbance, or uncontrolled intercurrent illness including active infection, arterial thrombosis, abnormal hyper-coagulation profile, or symptomatic pulmonary embolism) or would complicate the study.
• •17. Patient has any other condition that may cause an increased risk associated with the study participation or may interfere with the interpretation of study results, and in the opinion of the investigator, would make the patient inappropriate for entry into this study.
• •18. Patient is pregnant, lactating, or breastfeeding.