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Cannabinoid
Multiple myeloma: Chemo + BRCX014 for Glioblastoma
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
Study Summary
A Randomized, Double-Blind, Placebo-Controlled, Parallel, Multi-Center Study to Assess the Efficacy of BRCX014 Combined with Standard-Of-Care Treatment in Subjects with Glioblastoma Multiforme, Multiple Myeloma, and GI Malignancies
Eligible Conditions
- Glioblastoma
- Multiple Myeloma
- Pancreatic Cancer
- Liver Cancer
- Colorectal Cancer
- Gallbladder 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate
Secondary outcome measures
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 moreTrial 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: 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 VIII: 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 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
Cannabidiol
FDA approved
Bortezomib D-mannitol
FDA approved
Leucovorin
FDA approved
Fluorouracil
FDA approved
Oxaliplatin
FDA approved
Bevacizumab
FDA approved
Irinotecan
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
1 Trials studying Glioblastoma
21 Patients Enrolled for Glioblastoma
Sarah F Katta, DOPrincipal InvestigatorLeaf Vertical Inc.
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