Impact of Daily Oral Cannabis Doses in Patients With Cancer

Eligibility Criteria

• * Histologically or cytologically confirmed locally advanced or metastatic solid tumors with any types. This applies to either newly diagnosed cancer or preexisting ones on treatment.
• * Patients with active cancers and currently under any line of treatment (please see notable exceptions in the exclusion criteria - patients taking checkpoint inhibitors and investigational agents will not be eligible - also exclusionary medications).
• * Patients have been taking their current anti-cancer therapy regimen for at least one month prior to enrollment (to ensure no safety or toxicity issues with study drug initiation).
• * Age ≥18 years.
• * ECG and lab values demonstrating adequate organ and marrow function at baseline (pre-study).
• * Negative urine drug screen for all illicit drugs and THC, CBD prior to randomization
• * Ability to understand and the willingness to sign a written informed consent document
• * Individuals able to become pregnant will agree to practice an effective form of contraception (e.g., oral birth control pills, condoms, abstinence) for the duration of enrollment (note: urine pregnancy testing will occur monthly)
• * History of hypersensitivity to cannabis or cannabinoids
• * Current, regular use of cannabis/marijuana or THC-containing medications (dronabinol, nabilone) or cannabidiol (Epidiolex) or over-the-counter (OTC) CBD oil.
• * Concomitant use of checkpoint inhibitors (e.g., anti-PD1, PDL1, CTLA4) or other drugs for which an cannabinoid interaction may occur.
• * Current use of investigational agents, \<3 months after the use of investigational agents
• * Cardiac conditions contraindicated for cannabis use
• * Diagnosis of HPV-related cancer, as there is some evidence that cannabis is contraindicated
• * Allergy to any constituent/ingredient contained in the edible dose
• * Psychiatric illness/social situations that would limit compliance with study requirements (e.g., bipolar disorder, psychosis, severe depression/anxiety).
• * Pregnant or breastfeeding (note: participants will be tested for pregnancy (urine sample) once per month during enrollment)
• * Current moderate/severe drug or alcohol use disorder (including cannabis use disorder), positive urine drug screen for illicit drugs or cannabis, or positive alcohol (breathalyzer) during screening
• * History of seizure disorder, epilepsy (controlled or uncontrolled)
• * Current legal obligations (parole, probation, incarceration, urine drug screen requirements as part of parole/probation/previous incarceration)
• * Currently enrolled in substance use treatment
• * Self-reported cannabis and synthetic cannabinoid use in the past 30 days (medical or non-medical use is exclusionary)
• * Self-reported illicit drug use in past 60 days (ex: methamphetamine, heroin, illicit fentanyl)
• * Self-reported daily alcohol use
• * Providing a urine sample testing positive for cannabinoids (THC, CBD) or synthetic cannabinoids (K2, Spice-like compounds)
• * Providing a sample testing positive for alcohol (breathalyzer) or non-medical use of other drugs (methamphetamine, cocaine) during screening; testing positive during enrollment will lead to discontinuation of the participant's enrollment
• * No access to internet/data or devices needed to participate in daily video calls