A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies

Overseen By William Fisher

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Leaf Vertical Inc.

Disqualifiers: Pregnancy, Substance abuse, Depression, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

160 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

How does the drug Cannabidiol (CBD) differ from other treatments for breast cancer?

Cannabidiol (CBD) is unique because it is derived from cannabis and is being explored for its potential anti-cancer properties, which may differ from traditional chemotherapy or hormone therapies. Unlike conventional treatments, CBD is thought to interact with the body's endocannabinoid system, potentially offering a novel mechanism of action for managing cancer symptoms or progression. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests a new drug, BRCX014, combined with standard treatments for patients with certain hard-to-treat cancers. The drug aims to make chemotherapy more effective by targeting cancer cells without affecting normal cells.

Research Team

Sarah F Katta, DO

Principal Investigator

Leaf Vertical Inc.

Eligibility Criteria

Inclusion Criteria

Signed and dated informed consent

Confirmed tissue diagnosis of Multiple myeloma, GI malignancy by a licensed pathologist

A performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cannabidiol (BRCX014) combined with standard-of-care chemotherapy for various cancers, including multiple myeloma, glioblastoma multiforme, and GI malignancies

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cannabidiol

Participant Groups

Group I: Rectal: Chemo + BRCX014 Experimental Treatment 6 Interventions

Cannabidiol (BRCX014) 200 mg daily plus Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.

Group II: Pancreatic: Chemo + BRCX014 Experimental Treatment 2 Interventions

Cannabidiol (BRCX014) 200 mg daily plus Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.

Group III: Multiple myeloma: Chemo + BRCX014 Experimental Treatment 2 Interventions

Cannabidiol (BRCX014) 200 mg daily plus Standard of care (SOC) chemotherapy for multiple myeloma will include a bortezomib-based regimen given at 1.3 mg/m2 on days 1, 4, 8 \& 11 schedule to be repeated every 21 days.

Group IV: GBM: Chemo + BRCX014 Experimental Treatment 2 Interventions

Cannabidiol (BRCX014) 200 mg daily plus Standard of care chemotherapy for patients with glioblastoma multiforme includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle).

Group V: Colon: Chemo + BRCX014 Experimental Treatment 6 Interventions

Cannabidiol (BRCX014) 200 mg daily plus Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.

Group VI: Pancreatic: Chemo + Placebo Placebo Group 1 Intervention

Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.

Group VII: GBM: Chemo + Placebo Placebo Group 1 Intervention

Standard of care chemotherapy for patients with glioblastoma multiforme includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle).

Group VIII: Rectal: Chemo + Placebo Placebo Group 5 Interventions

Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.

Group IX: Colon: Chemo + Placebo Placebo Group 5 Interventions

Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.

Group X: Multiple myeloma: Chemo + Placebo Placebo Group 1 Intervention

Standard of care (SOC) chemotherapy for multiple myeloma will include a bortezomib-based regimen given at 1.3 mg/m2 on days 1, 4, 8 \& 11 schedule to be repeated every 21 days.

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

Leaf Vertical Inc.

Lead Sponsor

Trials

2

Recruited

180+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

High stearoyl-CoA desaturase 1 expression is associated with shorter survival in breast cancer patients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Overexpressed ACBD3 has prognostic value in human breast cancer and promotes the self-renewal potential of breast cancer cells by activating the Wnt/beta-catenin signaling pathway. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Stearoyl-CoA Desaturase Promotes Liver Fibrosis and Tumor Development in Mice via a Wnt Positive-Signaling Loop by Stabilization of Low-Density Lipoprotein-Receptor-Related Proteins 5 and 6. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Abrogation of de novo lipogenesis by stearoyl-CoA desaturase 1 inhibition interferes with oncogenic signaling and blocks prostate cancer progression in mice. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Stearoyl CoA desaturase (SCD) facilitates proliferation of prostate cancer cells through enhancement of androgen receptor transactivation. [2021]