Back to resultsA Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies
Primary Purpose
Cancer of Pancreas, Cancer of Liver, Cancer of Rectum
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol
Bortezomib
Leucovorin
5-FU
Oxaliplatin
Bevacizumab
Irinotecan
Gemcitabine
Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of Pancreas
Eligibility Criteria
Inclusion Criteria:
- Signed and dated informed consent
- Male and Females age 18 to 80 years old at the time of screening
- 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.
- Females of childbearing potential willing to utilize two approved forms of contraceptives (e.g., birth control, abstinence, spermicidal lube, intrauterine device [IUD])
- Male study subjects must be willing to use two approved forms of contraceptives (e.g., physical barrier-condoms, abstinence, spermicidal lube)
Exclusion Criteria:
- Subject is pregnant or plans to become pregnant or actively lactating/nursing
- Hypersensitivity to any ingredient in the study product
- Initial laboratory values as determined by the principal investigator to be clinically significant
- A substance abuse history within the last five years
- Any diseases or conditions that may interfere with the conduct of the study or interpretation of the study results
- .Close affiliation with the investigational site (e.g., a close relative of the investigator), dependent person (employee or student of investigational site, or sponsor's staff)
- Currently enrolled in another investigational clinical study
- A known history of severe depression or psychiatric disorders or active suicidal ideation
- Inability or unwillingness to cooperate with the study procedures for any reasons
Sites / Locations
- Southwest Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm Type
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Arm Label
Colon: Chemo + Placebo
Colon: Chemo + BRCX014
Rectal: Chemo + Placebo
Rectal: Chemo + BRCX014
Multiple myeloma: Chemo + Placebo
Multiple myeloma: Chemo + BRCX014
Pancreatic: Chemo + Placebo
Pancreatic: Chemo + BRCX014
GBM: Chemo + Placebo
GBM: Chemo + BRCX014
Arm Description
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.
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.
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.
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.
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 (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.
Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.
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.
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).
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).
Outcomes
Primary Outcome Measures
Response rate
The primary objective of this study is to evaluate the overall response rates of cancer patients as assessed by standard criteria.
Secondary Outcome Measures
Time to progression (TTP) in patients using lab results and radiographic data.
A secondary objective of this study is to measure TTP using lab results and radiographic data.
Progression-free survival (PFS) in patients using lab results and radiographic data.
A secondary objective of this study is to measure PFS using lab results and radiographic data.
Quality-of-life assessment in patients using patient-reported outcomes (PRO) data.
A secondary objective of this study is to collect patient-reported outcomes (PRO) data.
Quality-of-life assessment in patients using clinician-reported outcomes (ClinRO) data.
A secondary objective of this study is to collect clinician-reported outcomes (ClinRO) data.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03607643
Brief Title
A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies
Official Title
Randomized Double-Blind, Placebo-Controlled Parallel Multi-Center Study to Assess the Efficacy of Cannabidiol (BRCX014) Combined With Standard-Of-Care Treatment in Subjects With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Anticipated)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Leaf Vertical Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
Detailed Description
Several studies have shown a potential anti-tumor role for cannabinoids by modulating cell signaling pathways, inhibiting angiogenesis, inducing apoptosis, and overcoming chemotherapy resistance. In phase I trials, cannabinoids have been shown to enhance the uptake of chemotherapy into malignant cells without affecting normal cells. The investigators seeks to demonstrate that the combination of chemotherapy with BRCX014 will have a greater anti-tumor and anti-proliferative activity when compared to standard of care alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Pancreas, Cancer of Liver, Cancer of Rectum, Cancer of Colon, Cancer, Gall Bladder, Myeloma Multiple, Glioblastoma Multiforme
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Study length for randomized patients in the treatment group(s) will be 180 days. For those subjects randomized into the control group(s), after 90 days of the control group study treatment, will be given the choice to rollover into the treatment group. Crossover is also permitted if there is progression of disease before 90 days.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participant, care provider, investigator, and outcomes assessor will be blinded to standard of care (SOC) alone vs treatment arm
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Colon: Chemo + Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Colon: Chemo + BRCX014
Arm Type
Experimental
Arm Description
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.
Arm Title
Rectal: Chemo + Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Rectal: Chemo + BRCX014
Arm Type
Experimental
Arm Description
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.
Arm Title
Multiple myeloma: Chemo + Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Multiple myeloma: Chemo + BRCX014
Arm Type
Experimental
Arm Description
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.
Arm Title
Pancreatic: Chemo + Placebo
Arm Type
Placebo Comparator
Arm Description
Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.
Arm Title
Pancreatic: Chemo + BRCX014
Arm Type
Experimental
Arm Description
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.
Arm Title
GBM: Chemo + Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
GBM: Chemo + BRCX014
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Other Intervention Name(s)
BRCX014, bioRenovate CX
Intervention Description
Sublingual dose of 1 mL (0.910 g) of BRCX014 in the morning, prior to the first meal of the day
Sublingual dose of 1 mL (0.910 g) of BRCX014 in the afternoon, prior to the evening meal
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
Folinic acid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
Efudex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Camptosar
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
Temodar
Intervention Description
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).
Primary Outcome Measure Information:
Title
Response rate
Description
The primary objective of this study is to evaluate the overall response rates of cancer patients as assessed by standard criteria.
Time Frame
Through study completion, an average of one year
Secondary Outcome Measure Information:
Title
Time to progression (TTP) in patients using lab results and radiographic data.
Description
A secondary objective of this study is to measure TTP using lab results and radiographic data.
Time Frame
Through study completion, an average of one year
Title
Progression-free survival (PFS) in patients using lab results and radiographic data.
Description
A secondary objective of this study is to measure PFS using lab results and radiographic data.
Time Frame
Through study completion, an average of one year
Title
Quality-of-life assessment in patients using patient-reported outcomes (PRO) data.
Description
A secondary objective of this study is to collect patient-reported outcomes (PRO) data.
Time Frame
Through study completion, an average of one year
Title
Quality-of-life assessment in patients using clinician-reported outcomes (ClinRO) data.
Description
A secondary objective of this study is to collect clinician-reported outcomes (ClinRO) data.
Time Frame
Through study completion, an average of one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed and dated informed consent
Male and Females age 18 to 80 years old at the time of screening
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.
Females of childbearing potential willing to utilize two approved forms of contraceptives (e.g., birth control, abstinence, spermicidal lube, intrauterine device [IUD])
Male study subjects must be willing to use two approved forms of contraceptives (e.g., physical barrier-condoms, abstinence, spermicidal lube)
Exclusion Criteria:
Subject is pregnant or plans to become pregnant or actively lactating/nursing
Hypersensitivity to any ingredient in the study product
Initial laboratory values as determined by the principal investigator to be clinically significant
A substance abuse history within the last five years
Any diseases or conditions that may interfere with the conduct of the study or interpretation of the study results
.Close affiliation with the investigational site (e.g., a close relative of the investigator), dependent person (employee or student of investigational site, or sponsor's staff)
Currently enrolled in another investigational clinical study
A known history of severe depression or psychiatric disorders or active suicidal ideation
Inability or unwillingness to cooperate with the study procedures for any reasons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Arlen, PhD
Phone
407-443-0656
Email
parlen@leafvertical.com
First Name & Middle Initial & Last Name or Official Title & Degree
William Fisher
Phone
407-797-2332
Email
ceo@leafvertical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah F Katta, DO
Organizational Affiliation
Leaf Vertical Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Katta, DO
Phone
407-426-8660
Email
sarahfk1978@yahoo.com
First Name & Middle Initial & Last Name & Degree
Philip Arlen, PhD
Phone
407-443-0656
Email
parlen@leafvertical.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies
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