Ketamine-assisted Therapy for Advanced GI Cancer

Exclusion Criteria

• •1. Has a known allergic or severe reactions to the non-psychoactive components of liquid ketamine.
• •2. Has received treatment with another investigational drug or intervention within 1 month of signing Informed Consent Form (ICF).
• •3. Is deemed by clinical judgment of the study investigators to be unsafe for undergoing the intervention.
• •4. Recent use of ketamine for non-anesthesia purposes.
• •5. Frequent use of ketamine over lifetime.
• •6. Has a history of intra-cerebral hemorrhage.
• •7. Has cognitive impairment sufficient to impede the ability to complete study tasks.
• •8. Has had delirium/encephalopathy within 3 months of signing ICF.
• •9. Has a history of intracranial hemorrhage.
• •10. Has had a stroke (embolic) within 12 months of signing ICF.
• •11. Has had a seizure within 6 months of signing ICF.
• •12. Currently has an intracranial mass (e.g., primary tumor or brain metastasis).
• •13. Has an advanced stage of a neurologic disease that puts participants at elevated risk for psychosis (e.g., Parkinson or Huntington disease).
• •14. Has a history of a primary psychotic disorder or primary bipolar disorder I or II (determined by Quick Structured Clinical Interview for Diagnostic and Statistical Manual version 5 Disorders (QuickSCID-5)).
• •15. Has a history of dissociative disorder.
• •16. Recent active suicidal ideation. Note: This does not include requesting medical aid in dying.
• •17. Is currently receiving electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or similar somatic therapies.
• •18. Has baseline hypertension (≥150 SBP or ≥90 DBP), after repeated measurements. Note: Participants with hypertension that has been controlled by medication down to \<150 Systolic blood pressure (SBP) and \<90 diastolic blood pressure (DBP) will be allowed participate.
• •19. Has a history of aneurysmal vascular disease or dissection (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation.
• •20. Has had cardiac arrest within 12 months of signing ICF.
• •21. Has had a myocardial infarction within 12 months of signing ICF.
• •22. Has QT Corrected for Heart Rate using Fridericia's Formula (QTcf) \>480msec on 12-lead EKG. Note: Participants may qualify for the study if corrected QT Interval (QTc) 480-500 msec on one EKG, but then \<=480 msec on repeat EKG taken \>1 day later. If QT-prolonging medications are started or increased in dose after enrollment and prior to ketamine administration, a repeat EKG must be done \>12-hours after this change in order to assure continued safe enrollment in the trial.
• •23. Has clinically significant arrhythmia defined as
• •1. Ventricular fibrillation or ventricular tachycardia within 1 year of signing ICF
• •2. Bradycardia, severe, within 1 year of signing ICF Note: Participants with pacemakers will be considered to be eligible at the discretion of the Principal Investigator.
• •3. Atrial fibrillation, without rate or rhythm control
• •4. Supraventricular tachycardia (SVT), without standard treatment
• •5. Other clinically significant arrhythmias (e.g., Wolf Parkinson White)
• •24. Has symptomatic congestive heart failure (NYHA Class II-IV)
• •25. Has severe obstructive intracardiac abnormalities (e.g., aortic stenosis)
• •26. Has any current condition where physical activity is associated with palpitations, anginal pain or syncope.
• •27. Is unable to protect their own airway due to dysphagia, difficulty swallowing or a neurologic disease resulting in a risk of aspiration.
• •28. Has a history of flash pulmonary edema within 12 months of signing ICF.
• •29. Has a diagnosis of moderate or severe pulmonary hypertension.
• •30. Needs supplemental oxygen (intermittent or continuous).
• •31. Has current intractable nausea/vomiting/diarrhea.
• •32. Meets the following laboratory parameters:
• •1. Asymptomatic alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=5x upper limit of normal (ULN).
• •2. Symptomatic ALT or AST \>= 2x ULN.
• •3. Total bilirubin \> 2x ULN (Gilbert syndrome is allowed)
• •4. Alkaline phosphatase \>5x ULN
• •5. International Normalized Ratio (INR) \> 2.5 for patients with any history of cirrhosis or gastrointestinal bleeding within 6 months of signing ICF.
• •6. Renal insufficiency (i.e., estimated glomerular filtration rate (eGFR) \< 30 milliliter/minute (mL/min) /1.73 m\^2 (using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation), Creatinine Clearance (CrCl) \< 30 mL/min (using the Cockcroft-Gault Equation), or current dialysis)).
• •33. Is currently pregnant or breastfeeding.
• •34. Has insulin-dependent diabetes with diabetes-related hospitalization within 6 months of signing ICF.