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Cannabinoid
A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies
Phase 1 & 2
Waitlist Available
Led By Sarah F Katta, DO
Research Sponsored by Leaf Vertical Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of one year
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Summary
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.
Eligible Conditions
- Rectal Cancer
- Colon Cancer
- Multiple Myeloma
- Gallbladder Cancer
- Liver Cancer
- Glioblastoma
- Pancreatic Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response rate
Secondary study objectives
Progression-free survival (PFS) in patients using lab results and radiographic data.
Quality-of-life assessment in patients using clinician-reported outcomes (ClinRO) data.
Quality-of-life assessment in patients using patient-reported outcomes (PRO) data.
+1 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
10Treatment groups
Experimental Treatment
Placebo Group
Group I: Rectal: Chemo + BRCX014Experimental Treatment6 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 + BRCX014Experimental Treatment2 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 + BRCX014Experimental Treatment2 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 + BRCX014Experimental Treatment2 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 + BRCX014Experimental Treatment6 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 + PlaceboPlacebo Group1 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 + PlaceboPlacebo Group1 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 + PlaceboPlacebo Group5 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 + PlaceboPlacebo Group5 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 + PlaceboPlacebo Group1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
FDA approved
Irinotecan
FDA approved
Cannabidiol
FDA approved
Fluorouracil
FDA approved
Bevacizumab
FDA approved
Bortezomib D-mannitol
FDA approved
Leucovorin
FDA approved
Oxaliplatin
FDA approved
Gemcitabine
FDA approved
Find a Location
Who is running the clinical trial?
Leaf Vertical Inc.Lead Sponsor
1 Previous Clinical Trials
21 Total Patients Enrolled
Sarah F Katta, DOPrincipal InvestigatorLeaf Vertical Inc.