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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03607643
Recruitment Status : Not yet recruiting
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Leaf Vertical Inc.

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

Condition or disease Intervention/treatment Phase
Cancer of Pancreas Cancer of Liver Cancer of Rectum Cancer of Colon Cancer, Gall Bladder Myeloma Multiple Glioblastoma Multiforme Drug: Cannabidiol Drug: Bortezomib Drug: Leucovorin Drug: 5-FU Drug: Oxaliplatin Drug: Bevacizumab Drug: Irinotecan Drug: Gemcitabine Drug: Temozolomide Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participant, care provider, investigator, and outcomes assessor will be blinded to standard of care (SOC) alone vs treatment arm
Primary Purpose: Treatment
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
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 15, 2020


Arm Intervention/treatment
Placebo Comparator: Colon: Chemo + Placebo
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.
Drug: Leucovorin
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.
Other Name: Folinic acid

Drug: 5-FU
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.
Other Name: Efudex

Drug: 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.
Other Name: Eloxatin

Drug: Bevacizumab
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.
Other Name: Avastin

Drug: Irinotecan
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.
Other Name: Camptosar

Experimental: Colon: Chemo + BRCX014
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.
Drug: Cannabidiol
  • 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
Other Names:
  • BRCX014
  • bioRenovate CX

Drug: Leucovorin
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.
Other Name: Folinic acid

Drug: 5-FU
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.
Other Name: Efudex

Drug: 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.
Other Name: Eloxatin

Drug: Bevacizumab
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.
Other Name: Avastin

Drug: Irinotecan
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.
Other Name: Camptosar

Placebo Comparator: Rectal: Chemo + Placebo
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.
Drug: Leucovorin
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.
Other Name: Folinic acid

Drug: 5-FU
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.
Other Name: Efudex

Drug: 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.
Other Name: Eloxatin

Drug: Bevacizumab
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.
Other Name: Avastin

Drug: Irinotecan
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.
Other Name: Camptosar

Experimental: Rectal: Chemo + BRCX014
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.
Drug: Cannabidiol
  • 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
Other Names:
  • BRCX014
  • bioRenovate CX

Drug: Leucovorin
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.
Other Name: Folinic acid

Drug: 5-FU
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.
Other Name: Efudex

Drug: 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.
Other Name: Eloxatin

Drug: Bevacizumab
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.
Other Name: Avastin

Drug: Irinotecan
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.
Other Name: Camptosar

Placebo Comparator: Multiple myeloma: Chemo + Placebo
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.
Drug: Bortezomib
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.
Other Name: Velcade

Experimental: Multiple myeloma: Chemo + BRCX014
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.
Drug: Cannabidiol
  • 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
Other Names:
  • BRCX014
  • bioRenovate CX

Drug: Bortezomib
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.
Other Name: Velcade

Placebo Comparator: Pancreatic: Chemo + Placebo
Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.
Drug: Gemcitabine
Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.
Other Name: Gemzar

Experimental: Pancreatic: Chemo + BRCX014
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.
Drug: Cannabidiol
  • 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
Other Names:
  • BRCX014
  • bioRenovate CX

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

Placebo Comparator: GBM: Chemo + Placebo
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).
Drug: Temozolomide
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).
Other Name: Temodar

Experimental: GBM: Chemo + BRCX014
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).
Drug: Cannabidiol
  • 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
Other Names:
  • BRCX014
  • bioRenovate CX

Drug: Temozolomide
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).
Other Name: Temodar




Primary Outcome Measures :
  1. Response rate [ Time Frame: Through study completion, an average of one year ]
    The primary objective of this study is to evaluate the overall response rates of cancer patients as assessed by standard criteria.


Secondary Outcome Measures :
  1. Time to progression (TTP) in patients using lab results and radiographic data. [ Time Frame: Through study completion, an average of one year ]
    A secondary objective of this study is to measure TTP using lab results and radiographic data.

  2. Progression-free survival (PFS) in patients using lab results and radiographic data. [ Time Frame: Through study completion, an average of one year ]
    A secondary objective of this study is to measure PFS using lab results and radiographic data.

  3. Quality-of-life assessment in patients using patient-reported outcomes (PRO) data. [ Time Frame: Through study completion, an average of one year ]
    A secondary objective of this study is to collect patient-reported outcomes (PRO) data.

  4. Quality-of-life assessment in patients using clinician-reported outcomes (ClinRO) data. [ Time Frame: Through study completion, an average of one year ]
    A secondary objective of this study is to collect clinician-reported outcomes (ClinRO) data.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent
  2. Male and Females age 18 to 80 years old at the time of screening
  3. Confirmed tissue diagnosis of Multiple myeloma, GI malignancy by a licensed pathologist
  4. A performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  5. Females of childbearing potential willing to utilize two approved forms of contraceptives (e.g., birth control, abstinence, spermicidal lube, intrauterine device [IUD])
  6. Male study subjects must be willing to use two approved forms of contraceptives (e.g., physical barrier-condoms, abstinence, spermicidal lube)

Exclusion Criteria:

  1. Subject is pregnant or plans to become pregnant or actively lactating/nursing
  2. Hypersensitivity to any ingredient in the study product
  3. Initial laboratory values as determined by the principal investigator to be clinically significant
  4. A substance abuse history within the last five years
  5. Any diseases or conditions that may interfere with the conduct of the study or interpretation of the study results
  6. .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)
  7. Currently enrolled in another investigational clinical study
  8. A known history of severe depression or psychiatric disorders or active suicidal ideation
  9. Inability or unwillingness to cooperate with the study procedures for any reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607643


Contacts
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Contact: Philip Arlen, PhD 407-443-0656 parlen@leafvertical.com
Contact: William Fisher 407-797-2332 ceo@leafvertical.com

Locations
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United States, Florida
Southwest Cancer Center Not yet recruiting
Orlando, Florida, United States, 32806
Contact: Sarah Katta, DO    407-426-8660    sarahfk1978@yahoo.com   
Contact: Philip Arlen, PhD    407-443-0656    parlen@leafvertical.com   
Sponsors and Collaborators
Leaf Vertical Inc.
Investigators
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Principal Investigator: Sarah F Katta, DO Leaf Vertical Inc.

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Responsible Party: Leaf Vertical Inc.
ClinicalTrials.gov Identifier: NCT03607643     History of Changes
Other Study ID Numbers: Olympian
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Epidiolex
Multiple Myeloma
Neoplasms, Plasma Cell
Glioblastoma
Pancreatic Neoplasms
Liver Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Gallbladder Neoplasms
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site