Cannabidiol for Multiple Myeloma and Glioblastoma

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of cannabidiol, a compound from cannabis, when combined with standard treatments for certain cancers. It targets individuals with glioblastoma multiforme (a type of brain cancer), multiple myeloma (a blood cancer), and advanced gastrointestinal cancers such as colon and rectal cancer. Participants will receive either cannabidiol with their regular chemotherapy or a placebo (a non-active substitute). Those diagnosed with these specific cancers and managing daily life while receiving standard cancer treatments may be suitable candidates for this study. As a Phase 1, Phase 2 trial, the research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In earlier studies, cannabidiol (CBD) has shown promise as a treatment for various cancers, including colon and rectal cancer. Research indicates that CBD can inhibit cancer cell growth and spread, suggesting it might be safe for individuals with these cancers.

For pancreatic cancer, studies have found that CBD can enhance the effectiveness of other treatments and might reduce chemotherapy side effects, indicating it could be a safe option for patients.

Regarding multiple myeloma, research suggests that CBD might alleviate side effects from cancer treatment and works well with other cancer drugs. Safety data for CBD in multiple myeloma patients indicate it is well-tolerated.

For glioblastoma multiforme (a type of brain cancer), studies suggest that CBD might extend patient survival and inhibit cancer cell spread. Although more research is needed, these findings indicate that CBD is generally safe for humans.

In summary, current research supports the safety of CBD for these types of cancer. It appears to be well-tolerated and may improve treatment outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Cannabidiol (BRCX014) for conditions like multiple myeloma, glioblastoma multiforme, and certain GI cancers because it offers a fresh approach compared to standard chemotherapy. Unlike traditional treatments that primarily target rapidly dividing cells, cannabidiol has the potential to modulate the endocannabinoid system, which may help in reducing inflammation and potentially slowing cancer growth. This unique mechanism could mean fewer side effects associated with conventional chemotherapy, making it a promising complementary therapy. Additionally, cannabidiol's anti-inflammatory properties and ability to enhance the effectiveness of existing treatments are particularly appealing to researchers.

What evidence suggests that this trial's treatments could be effective?

Research has shown that cannabidiol (CBD), studied in this trial, might help combat various types of cancer, including those targeted in this study. Participants will receive either CBD (BRCX014) or a placebo alongside standard chemotherapy. For colorectal cancer, studies suggest that CBD can slow the growth and spread of cancer cells. In pancreatic cancer, research has linked CBD to longer survival and smaller tumors in early tests. For multiple myeloma, CBD appears to enhance the effectiveness of standard treatments and reduce cancer cell survival. In glioblastoma multiforme, a type of brain cancer, CBD may extend patient survival and improve the effects of other treatments. These findings indicate that CBD could be promising in treating these cancers, but further research is needed to confirm these effects in people. ^{1 2 6 7 8}

Who Is on the Research Team?

Sarah F Katta, DO

Principal Investigator

Leaf Vertical Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12293229/

Cannabidiol (CBD) and Colorectal Tumorigenesis: Potential ... Early preclinical studies suggest that cannabidiol may help to combat colorectal cancer by influencing how cancer cells grow and die. One of the possible ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8869992/

Cannabidiol (CBD) in Cancer Management - PMC CBD was shown to significantly decrease adhesion to endothelial cells and migration of HCT116 cells (metastatic colon cancer cell line), an inhibitory effect ...

3. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i490/7967046

P0112 Cannabidiol (CBD) targeting of colorectal cancer cells ... Our results demonstrate that CBD induces apoptosis and halts proliferation, migration, and invasion of CRC cells in a concentration dependent manner.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03607643?term=BRCX014%20&rank=2

NCT03607643 | A Study of the Efficacy of Cannabidiol ... Several studies have shown a potential anti-tumor role for cannabinoids by modulating cell signaling pathways, inhibiting angiogenesis, inducing apoptosis, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2095177923000746

Single-cell analyses reveal cannabidiol rewires tumor ... Here, we report that CBD inhibits colorectal cancer progression by modulating the suppressive tumor microenvironment (TME).

6. pubs.acs.org pubs.acs.org/doi/10.1021/acsptsci.4c00644

Cannabidiol Targets Colorectal Cancer Cells via Cannabinoid ... Our results demonstrate that CBD induces apoptosis and halts proliferation, migration, and invasion of CRC cell lines in a concentration-dependent manner.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1567576922003496

Cannabidiol exerts anti-proliferative activity via a ... The potential use of CBD in treating cancer is supported by many observations showing its anti-cancer activity in diverse types of cancer including colon, ...

8. oncodaily.com oncodaily.com/oncolibrary/colorectal-cancer-and-cannabis

Colorectal Cancer and Cannabis : Who's Winning the ... Cannabis compounds, especially cannabinoids THC, CBD, and CBG, have shown promising anticancer effects in preclinical studies. They can induce ...