Behaviors and Mental Disorders

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Breast Neoplasms

Breast Diseases

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All Drugs and Chemicals

Cannabidiol

After screening procedures confirm participation in the research study, participants will be randomized one of two groups:

* Participants in the experimental arm will complete questionnaires and then receive a single dose of CBD prior to diagnostic CT scan or positron emission tomography (PET) .
* Cannabidiol: Oral, per protocol dosage, single dose
* Additional questionnaires 2 hours post scan and follow up via phone call 1 week regarding experience

After the screening procedures confirm participation in the research study, participants will be randomized one of two groups:

* Participants in the placebo arm will complete questionnaire and then receive a single dose of placebo prior to diagnostic CT scan or positron emission tomography (PET) .
* Placebo: Oral, per protocol dosage, single dose
* Additional questionnaires 2 hours post scan and follow up via phone call 1 week regarding experience

Placebo

Ilana Braun, MD

This research study is investigating use of a single dose of cannabidiol (CBD) to help manage anticipatory anxiety in participants with advanced breast cancer poised to undergo computed tomography (CT) or positron emission tomography (PET) to assess tumor burden.

The name of the study drug(s) are:

- Cannabidiol (CBD)

This is a randomized, double-blind, placebo-controlled Phase II trial of a single dose of CBD for acute anticipatory anxiety in patients with advanced breast cancer undergoing computed tomography (CT) or positron emission tomography (PET) to assess tumor burden.

The research study investigates use of CBD to manage anxiety prior to an oncologic imaging scan. CBD is a component of the cannabis sativa (marijuana) plant and of hemp. Studies of CBD have led to its approval by the Food and Drug Administration for certain childhood seizure disorders. Researchers have also been studying the use of CBD to manage anxiety and pain.

This study is designed to learn if the drug can help reduce anxiety and can safely be given to participants with advanced breast cancer who are scheduled for a CT or PET scan.

* After screening procedures confirm participation in the research study, participants will be "randomized" into one of two study groups: one group will receive CBD, the other group will receive a placebo of flavored corn syrup.
* Randomization means that participants are put into a group by chance. Neither the participant nor the research team will choose participant group assignment.

  * Participants will have a 66% chance of receiving a single dose of CBD.
  * Participants will have a 33% chance of receiving a single dose of placebo.
* On the day of treatment, participants will complete questionnaires before and after receiving a single dose of CBD or placebo then undergo computed tomography (CT) scan or positron emission tomography (PET). Participants will be contacted by phone approximately a week later and interviewed about study drug consumption and the CT/PET scan experience.

This study is supported by funding from the Hans and Mavis Lopater Foundation.

Approximately 50 people are anticipated to take part in this study.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved CBD to manage anxiety but it has been approved for use in children with some seizure disorders.

RCT of CBD for Anxiety in Advanced Breast Cancer

Randomized, Double-blind Phase II Study of a Single Dose of Cannabidiol (CBD) for Acute Anticipatory Anxiety in Advanced Breast Cancer

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The change in anxiety score will be calculated for each patient and a Wilcoxon rank sum test will be used to assess whether the change score is different among patients randomized to CBD as compared to placebo.

Measured using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) and a qualitative assessment, patient-reported side effects and acceptability of taking oral CBD (versus placebo) for managing anticipatory anxiety.

Measured by VAMS subscales-The Visual Analog Mood Scale (VAMS) a validated in-the-moment measure of eight specific mood states: Afraid, Confused, Sad, Angry, Energetic, Tired, Happy, and Tense. Subjects are asked to mark their mood along this continuum. The measure is scored using a metric ruler

Measured by the European Organisation for Research and Treatment of Cancer core quality of life questionnaire-nausea subscale.

The EORTC-QLQc30 is a widely used and validated measure of symptom burden.

Pain levels (as measured by the PEG) 3 +/- 1 hour after study agent administration in patients with advanced cancer.

pain intensity scale is scored from 0 to 10 (with 10 representing "worst possible" pain).

Hans and Mavis Lopater Foundation

Dana-Farber Cancer Institute

Principal Investigator

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Bendamustine Hydrochloride

Dexamethasone acetate

Carfilzomib

Open-label phase Ib/II, multicenter, international non-comparative trial. This study is designed to determine the safety and efficacy of the novel salvage regimen (CBd) followed by a carfilzomib maintenance in patients with relapsed or refractory multiple myeloma.

Patients will be evaluated at scheduled visits in up to 4 study periods:

pretreatment, treatment, maintenance and long-term follow-up (LTFU).

Multiple myeloma (MM) is one of the most common hematological diseases and besides the option of an allogeneic stem cell transplantation remains incurable.

Although autologous stem cell transplantation and new compounds such as bortezomib, thalidomide and lenalidomide have been implemented, treatment alternatives in patients who relapse or are refractory to these therapies are urgently needed. In addition, patients are often compromised by the toxicity of prior treatments not allowing further use of active drugs such as due to neurotoxicity when bortezomib was given. However, in contrast to bortezomib the investigative drug carfilzomib blocks, the proteasome irreversibly and shows minimal activity against off-target enzymes leading to more sustained proteasome inhibition with a distinctive toxicity profile \[1-3\]. Carfilzomib had promising single agent activity in a phase II trial with heavily pre-treated MM patients (overall response rate 24% \[4\]). Another drug with substantial activity in lymphoid malignancies is bendamustine, which was recently been found to be superior to chlorambucil in chronic lymphocytic leukemia (CLL) \[5\] as well as in Non-Hodgkin's lymphomas (NHL)\[6\]. In multiple myeloma, bendamustine combined with prednisone (BP) was superior to melphalan and prednisone (MP) as far as complete remission rate, time to treatment failure and life quality \[7\].

Therefore, bendamustine, an alkylating agent, was recently licensed in Europe for NHL, CLL and MM. The addition of bendamustine was able to overcome bortezomib resistance in an institutional treatment algorithm \[8\] in line with the observation that bortezomib enhanced the clinical activity of the alkylator melphalan in conventional doses as well as in the high dose setting \[9-10\]. Thus, there appears to be a rationale to combine both drugs in order to obtain clinical synergistic activity in relapsed and refractory MM patients.

STUDY OBJECTIVES

Primary objective:

* The dose-limiting toxicity (DLT) and maximum tolerate dose (MTD) of carfilzomib, bendamustine and dexamethasone (CBd) association (phase Ib).
* Determine the rate of very good partial response (VGPR) or more with the CBd association: a VGPR rate of 20% (p0) is considered not promising (H0) and a 40% (p1) as interesting (phase II).

Secondary objectives:

* Determine the overall response rate (ORR) after completion of CBd
* Determine the progression-free survival (PFS) after completion of CBd
* Determine the time point of best response
* Determine the time to progression (TTP)
* Determine the disease free survival (DFS)
* Determine the duration of response (DOR)
* Determine the time to next therapy (TTNT)
* Determine the overall survival (OS)
* Determine whether tumor response and survival might significantly change in particular subgroups of patients defined on prognostic factors (B2- microglobulin, C-reactive protein, cytogenetic abnormalities as determined by FISH) STUDY POPULATION Relapsed or refractory multiple myeloma after failure of two or more treatment regimens. Up to 68 patients will be enrolled from different centers. INCLUSION CRITERIA
* Patient ≥ 18 years old.
* Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
* Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
* Female patient is either post-menopausal or surgically sterilized or commits continued abstinence from heterosexual intercourse during the duration of the study or is willing to use two methods of birth control, one highly effective method and one additional effective method at the same time, at least 4 weeks before starting carfilzomib and bendamustine therapy, during carfilzomib and bendamustine therapy and for at least 4 weeks after stopping carfilzomib and bendamustine therapy. Highly effective methods are hormonal contraceptives (birth control pills, injections, and implants), intrauterine device, tubal ligation and partner's vasectomy. Additional effective methods are condom, diaphragm, and cervical cap. Women with child bearing potential must have two negative pregnancy tests (sensitivity at least 50 mIU/mL) prior starting carfilzomib and bendamustine therapy. The first pregnancy test must be performed 10 - 14 days and the second within 24 hours before starting carfilzomib and bendamustine therapy. Pregnancy testing for the first 4 weeks of study therapy must be performed weekly and thereafter every 4 weeks if menstrual cycles are regular or every 2 weeks if menstrual cycles are irregular.
* Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study and for 6 months after stopping study therapy.
* Patient with relapsed or/and refractory multiple myeloma after failure of two or more treatment regimens (previous bortezomib is allowed).
* Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein (M-protein) value (generally, but not necessarily, ≥ 0.5 g/dL of M-protein) and, where applicable, urine light-chain excretion of \>200 mg/24 hours. For patients with oligo- or non-secretory MM, it is required that they have measurable plasmacytoma \> 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an abnormal free light chain ratio (n.v.: 0.26-1.65). We anticipate that less than 10% of patients admitted to this study will be oligo- or non-secretory MM with free light chains only in order to maximize interpretation of benefit results.
* Patient has a Karnofsky performance status ≥60%.
* Patient has a life expectancy \>6 months.
* Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1, before study drug administration):

  * Platelet count ≥70 x 109/L (≥50 x 109 /L if myeloma involvement in the bone marrow is \> 50%) within 14 days prior to drug administration).
  * Absolute neutrophil count (ANC) ≥ 1 x 109/L without the use of growth factors.
  * Corrected serum calcium ≤14 mg/dL (3.5 mmol/L).
  * Alanine transaminase (ALT): ≤ 3 x the ULN.
  * Total bilirubin: ≤ 2 x the ULN.
  * Calculated or measured creatinine clearance ≥ 15 mL/min (or, as alternative serum creatinine \<2 mg/dL).
  * LVEF ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available (not applicable in Germany). EXCLUSION CRITERIA
* Pregnant or lactating females
* Patient has active infectious hepatitis type B or C or HIV.
* Patients with active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention.
* Peripheral neuropathy (PN) \> CTCAE grade 2 and ≥ grade 2 painful PN (with the difference being in the exclusion of patients with Grade 2 painful PN).
* Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
* Known history of intolerability to high dose dexamethasone
* Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and anti-platelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.
* Subject with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to baseline;
* Patient has any other clinically significant illness that would, in the investigator's opinion, increase the patient's risk for toxicity.
* Patient with a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma of the skin, or in situ cancer of the cervix or breast, or localized prostate cancer of Gleason score \<7 with a stable PSA). The pre-treatment period includes screening visits, performed at study entry. After providing written informed consent to participate in the study, patients will be evaluated for study eligibility. The screening period includes the availability of inclusion criteria described above. The treatment period includes administration of CBd for 8 courses. In order to assess the toxicity of treatment, patients will attend the study center visits at each scheduled carfilzomib administration. The response will be assessed after each cycle. The maintenance period will start at the end of 8th course, if the patient achieved at least Stable Disease (SD), and will stop at progression or intolerance. Patients will attend the study center visits at each scheduled carfilzomib administration.

The response will be assessed after each cycle. The median expected duration of the maintenance treatment is approximately 1 year. The LTFU period will start after development of confirmed progressive disease (PD). All patients are to be followed for survival during the LTFU period every 3 months via telephone or office visit. STUDY TREATMENT Patients will start the savage treatment with CBd, as soon as the screening visits of the pre-treatment period have been terminated. Patients will receive 8 CBd cycles. PHASE I In the phase I part of the study, the following dose levels of carfilzomib and bendamustine will be studied with a constant dose of dexamethasone: Level -2 Carfilzomib = 20 mg/m2 IV once daily on days 1, 2 of cycle 1 only followed by 27 mg/m2 days 8, 9, 15, 16 in cycle 1, then for all subsequent doses 27 mg/m2 once daily on days 1, 2, 8, 9, 15, 16 followed by 13-day rest period (day 17 through 28). Bendamustine = 50 mg/m2 on days 1, 8 every 28 days Dexamethasone = 20 mg on days 1, 2, 8, 9, 15, 16, 22, 23 every 28 days. Level -1 Carfilzomib = 20 mg/m2 IV once daily on days 1, 2 of cycle 1 only followed by 27 mg/m2 days 8, 9, 15, 16 in cycle 1, then for all subsequent doses 27 mg/m2 once daily on days 1, 2, 8, 9, 15, 16, followed by 13-day rest period (day 17 through 28). Bendamustine = 60 mg/m2 on days 1, 8 every 28 days Dexamethasone = 20 mg on days 1, 2, 8, 9, 15, 16, 22, 23 every 28 days . Level 0 Carfilzomib = 20 mg/m2 IV once daily on days 1, 2 of cycle 1 only followed by 27 mg/m2 days 8, 9, 15, 16 in cycle 1, then for all subsequent doses 27 mg/m2 IV once daily on days 1, 2, 8, 9, 15, 16 followed by 13-day rest period (day 17 through 28). Bendamustine = 70 mg/m2 on days 1, 8 every 28 days Dexamethasone = 20 mg on days 1, 2, 8, 9, 15, 16, 22, 23. Level +1 Carfilzomib = 20 mg/m2 IV once daily on days 1, 2, of cycle 1 only followed by 36 mg/m2 days 8, 9, 15, 16 in cycle 1, then for all subsequent doses 36 mg/m2 IV once daily on days 1, 2, 8, 9, 15, 16, followed by 13-day rest period (day 17 through 28). Bendamustine = 70 mg/m2 on days 1, 8 every 28 days Dexamethasone = 20 mg on days 1, 2, 8, 9, 15, 16, 22, 23. Level +2 Carfilzomib = 20 mg/m2 IV once daily on days 1, 2, of cycle 1 only followed by 45 mg/m2 days 8, 9, 15, 16 in cycle 1, then for all subsequent doses 45 mg/m2 IV once daily on days 1, 2, 8, 9, 15, 16, followed by 13-day rest period (day 17 through 28). Bendamustine = 70 mg/m2 on days 1, 8 every 28 days Dexamethasone = 20 mg on days 1, 2, 8, 9, 15, 16, 22, 23. Patients will be observed during the first two cycles of therapy for the assessment of side effects and observation of DLTs.

Dose escalation will proceed as follows:

* 3 patients will be entered at dose level 0.
* If none of the 3 experience DLT, dose escalation will continue.
* If one of three patients experience DLT, three additional patients will be added to this cohort (max 6).
* If two of three patients experience a DLT at any given dose, the MTD will have been exceeded and the MTD will be the preceding dose at which \< one of 6 patients experienced a DLT. If dose level zero is not tolerated, the next level will be level -1.
* If no further patients experience DLT (1 of 6) dose escalation will continue.
* If 2 patients experience DLT (2 of 6) the MTD will have been exceeded and the MTD will be the previous dose at which \<1 patient of 6 experienced DLT. PHASE II In the second part of the study, the MTD of the association CBd (or in absence of any MTD observed the doses of dose level 2) will be administered, if no dose level will be superior in phase Ib, to a total of 50 consecutive patients in order to assess response rate and clinical efficacy. MAINTENANCE PERIOD

At the end of 8 courses, maintenance phase will start. Patients will receive:

Carfilzomib = 27 mg/ m2 IV on days 1, 2, 15, 16 followed by 13-day rest period (day 17 through 28). Dexamethasone = 20 mg on days 1, 2, 8, 9, 15, 16, 22, 23. Patients will be stopped at PD or intolerance. STUDY ENDPOINTS

Primary endpoints:

All patients will be included in the Intent-to-Treat (ITT) analysis.

DLTs are defined as the following:

* Any CTCAE grade ≥3 non-hematologic event except the following:

  1. Nausea or vomiting that responds symptomatic therapy.
* Grade 4 neutropenia lasting more than 7 days.
* Grade 4 hematologic toxicity except neutropenia
* Development of febrile neutropenia defined as grade 3-4 neutropenia with fever 38.5°C and/or infection requiring antibiotic or antifungal treatment. Assessment of DLT defining adverse events will be performed after completion of the second cycle (only in phase Ib) according to the National Cancer Institute Common Terminology Criteria of Adverse Events (CTCAE version 4.0). Efficacy will be assessed by considering VGPR following the proposed regimen, according to the criteria of the International Myeloma Working Group

Secondary endpoints:

* Determine the ORR.
* Determine the PFS.
* Determine the time point of best response.
* Determine the TTP.
* Determine the DFS.
* Determine the DOR.
* Determine TTNT.
* Determine OS. Determine whether tumor response and survival might significantly change in particular subgroups of patients defined on prognostic factors (β2-microglobulin, C-reactive protein (CRP), cytogenetic abnormality or previous treatment). STATISTICAL METHODS The sample size of the first part of the study (Phase I) is based on the scenario that groups assuming CBd dose level -1/+2 are made of minimum 3 patients and maximum 6 patients. This brings a total of 18 patients, as maximum number of patients that will be recruited. The sample size of the second part of the study (Phase II) was estimated according to the Two-stage Simon phase II design, with early stopping rules, in case efficacy results lower than a predefined uninteresting response rate. A VGPR rate of 20% (p0) is considered not promising (H0) and a 40% (p1) VGPR rate as interesting; a probability of type I (α) error is set to be 0.05 and type II (β) error 0.20. In the first stage, 13 patients will be accrued. If 3 or less response will be observed in stage I, the trial will be stopped for futility. Otherwise, 30 additional patients will be accrued in the second stage: if 12 or fewer responses will be observed by the end of the stage II, then no further investigation will be warranted. With this design, and if H0 would be true, the expected number of enrolled patients will be 43 and the probability of early termination 74.7%. Assuming 10-15% of patients lost to follow-up, an adequate sample size will be 50 patients. Therefore the maximum total number of patients that will be recruited in both phases will be 68.

STUDY DURATION:

Approximately 5 years

TOTAL SAMPLE SIZE:

Up to 68 patients

STUDY DRUG SUPPLIERS:

Mundipharma International Onyx Pharmaceuticals

Carfilzomib In Combination With Bendamustine And Dexamethasone In Refractory Or Relapsed Multiple Myeloma

CARFILZOMIB IN COMBINATION WITH BENDAMUSTINE AND DEXAMETHASONE IN REFRACTORY OR RELAPSED MULTIPLE MYELOMA - A MULTICENTER PHASE IB/II TRIAL OF THE EUROPEAN MYELOMA NETWORK TRIALIST GROUP (EMNTG)

DLTs are defined as the following:

* Any CTCAE grade ≥3 non-hematologic event except the following:

  1. Nausea or vomiting that responds symptomatic therapy.
* Grade 4 neutropenia lasting more than 7 days.
* Grade 4 hematologic toxicity except neutropenia
* Development of febrile neutropenia defined as grade 3-4 neutropenia with fever 38.5°C and/or infection requiring antibiotic or antifungal treatment. Assessment of DLT defining adverse events will be performed after completion of the second cycle (only in phase Ib) according to the National Cancer Institute Common Terminology Criteria of Adverse Events (CTCAE version 4.0). Efficacy will be assessed by considering VGPR following the proposed regimen, according to the criteria of the International Myeloma Working Group

Determine the rate of very good partial response (VGPR) or more with the CBd association: a VGPR rate of 20% (p0) is considered not promising (H0) and a 40% (p1) as interesting (phase II).

Fondazione EMN Italy Onlus

Stichting European Myeloma Network

Substance Related Disorders

Marijuana Abuse

High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD.

Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD.

Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD.

High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD. The MPL-001 oil is produced by MediPharm Labs, each ml contains 50mg CBD and 2mg THC.

MPL-001

Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD. The MPL-005 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 5mg THC.

MPL-005

Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD. The MPL-009 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 25mg THC.

MPL-009

Lauren Kelly, PhD

Rod Rassekh, MD

Bruce Crooks, MD

Adam Rappoport, MD

CANnabinoids in Pediatric ONCology is a randomized, double blind, adaptive clinical trial looking at the tolerability of cannabinoids in children with cancer across 3 Canadian children's hospitals.

This is a multi-centered, pragmatic, double-blind, adaptive, dose-escalation study to establish the tolerability of Cannabis Herbal Extracts (CHE) containing different ratios of delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Study arms will contain the following ratios THC:CBD 1:25 (arm 1), 1:5 (arm 2) and 1:1 (arm 3). CAN-PONC will enroll 20 participants recruited into each arm, for a total of 60 study participants.

To inform the dose for the arm containing the most THC, this study will take place in two stages. In Stage One: The first 20 participants will be randomized 1:1 into arm 1 and arm 2. Once 20 participants have been recruited, trial recruitment will halt until the last participant reaches the maintenance phase, the maximum THC dose at which less than 30% of participants reported dose limiting toxicities (Max-D30) has been established, the remaining 40 recruited participants will be randomized 1:1:2 into arm 1, arm 2 and arm 3 in Stage Two of this study.

All arms consist of three phases: baseline phase (no interventional product for two weeks), treatment phase (dose escalations for eight weeks), and a maintenance phase (maximum tolerated dose for four weeks).

CANnabinoids in Pediatric ONCology

A Randomized, Double-Blind Tolerability Trial of Cannabinoids for Symptom Management in Children With Cancer: the CAN-PONC Trial

No. Summary level data may be available from the CAN-PONC steering committee following research ethics board approval.

Pain will be measured using Faces Pain Scale-Revised reported by the participants daily throughout the study. Pain will be reported for each study visit as a percentage change from the weekly average documented at baseline.

Symptom burden is measured using the score of Symptom Screening in Pediatrics Tool (SSPedi) assessed three times a week throughout the study and will be reported as a weekly average and percentage change from baseline.

Pediatric quality of life inventory (PedsQLTM) will be assessed weekly throughout the study

Sleep, will be reported as the number of hours per night, measured using Actigraphy and/or parent report, will be reported as an average over a one-week time period.

The Canadian Collaborative for Childhood Cannabinoid Therapeutics

Canadian Cancer Society (CCS)

Canadian Institutes of Health Research (CIHR)

University of Manitoba

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Bile Duct Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Pancreatic Cancer

Bile Duct Cancer

-In group A, SO should be preserved without sphincterotomy, but small infundibulotomy with needle knife can be accepted for cannulation.

-In group B, small sphincterotomy (50% incision) will be done after biliary cannulation.

The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.

PTFE Covered ComVi [full covered] Biliary Stent

Dong Ki Lee, PH.D

The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in malignant bile duct obstruction.

Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi

Prospective Randomized Trial Comparing Covered Metal Stents Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction: A Multi-nation, Multi-center Study

Taewoong Medical Co., Ltd.

General manager

Symptoms and General Pathology

Pain

Chronic Graft Versus Host Disease

Analgesics

Psychotropic Drugs

Dronabinol

10mg capsules Cannabidiol (CBD) +THC tetrahydrocannabinol (CBD 5mg + (THC)

Participants will be randomized to CBD 10mg capsules for 12 weeks. Participants will start with 1, CBD (10mg) capsule per day and self-titrate up to 8, 10mg CBD capsules (80mg) per day as needed.

Participants will be randomized to CBD+THC 10mg (CBD 5mg + THC) for 12 weeks. Participants will start with 1, 10mg CBD+THC (5mg+5mg) capsule per day and self- titrate up to 8, 10mg CBD+THC (5mg+5mg) capsules to a maximum of 80mg (40mg CBD + 40mg THC) per day as needed.

CBD+THC

Participants randomized to placebo 10mg capsules for 12 weeks. Participants will start with 1, 10mg placebo capsule per day and self-titrate up to 8 10mg placebo capsules (80mg) per day.

Lisa L Patterson, BA

Lisa L Patterson

Ashley Villarruel

Cannabis is being prescribed medically for chronic non-cancer pain despite limited evidence whether or not it works to reduce average pain in patients with chronic non-cancer pain. The cannabis plant (Cannabis sativa, Cannabis indica) consists of several hundred compounds of which, approximately 70 of which are thought to be active. The two active cannabinoids of interest in this trial are tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD). The goal of this trial is to determine whether CBD or CBD+THC reduces the average pain in participants with chronic non-cancer pain. The investigators also aim to determine whether CBD or CBD+THC is associated with a reduction in pain severity, pain interference, anxiety, depression, insomnia, opioids and use of benzodiazepines, analgesics, antidepressants, anxiolytics, or hypnotics amongst chronic non-cancer pain patients or an increase in physical functioning, physical health related role limitations, social functioning, mental functioning.

Cannabis Oil for Chronic Non-Cancer Pain Treatment

Cannabis Oil for Chronic Non-CancEr Pain Treatment [CONCEPT] - Alpha (α): A Randomized Controlled Trial

Relative change in Average Pain Score measured by the Average Pain Score ( 0=No Pain and 10=Pain as bad as you can imagine) from the Numeric Rating Scale

Decrease in Pain Severity Score measured by composite of 4 pain items (worst, least, average, now with 0=No Pain and 10=Pain as bad as you can imagine) (mean severity score) from the Brief Pain Inventory

Improved Pain Intensity Score measured by mean of 7 severity items (general, activity, walking, work, mood, enjoyment of life, relations with others and sleep with 0=No Pain and 10=Pain as bad as you can imagine) from the Brief Pain Inventory

Increase in Physical Functioning Score measured by the SF-36V2. 10 items in this scale represent levels and kinds of limitations between the extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling or stooping and walking moderate distances. One self-care item is included to represent limitations in self-care activities. This scale captures both the presence and existent of physical limitations using a three-level response continuum. Low scores indicate significant limitations in performing physical activities, while high scores reflect little or no such limitations.

Increase in Mental Health (MH) Score measured by the SF-36V2. This 5-item scale includes one or more items from each of four major mental health dimensions (anxiety, depression, loss of behavioral/emotional control, and psychological wellbeing). Low scores on MH are indicative of frequent feelings of nervousness and depression, while high scores indicate feelings of peace, happiness, and calm all or most of the time.

Increase in Social Functioning (SF) Score measured by the SF-36V2. This 2-item scale assesses health-related effects on quantity and quality of social activities, asking specifically either physical or emotional problems on social activities. The degree to which physical and emotional problems interfere with normal social actives increases with decreasing SF scores. The lowest score is related to extreme or frequent interference with normal social actives due to physical and emotional problems; the highest score indicates that the individual performs normal social activities without interference from physical or emotional problems..

Decrease in Physical Health-related Role Limitations measured by the SF-36V2. This 4-item scale covers an array of physical health-related role limitations, including a) limitations in the kind of work or other usual activities, b) reduction in the amount of time spend on work or other usual activities, c) difficulty performing work or other usual activities, and d) accomplishing less. Low scores on this scale reflect problems with work or other actives as a result of physical problems. High scores indicate little or no problems with work or other daily activities.

Improvement in Depression score measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 depression severity is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively. PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.

Improvement in Depression score measured by the Generalized Anxiety Disorder (GAD-7). This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively. GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cutpoints for mild, moderate, and severe anxiety, respectively.

Improvement in the Sleep Quality Score measured by the Insomnia Severity Index (ISI).Improvement in the Sleep Quality Score measured by the Insomnia Severity Index (ISI). Seven question added to get total score (0-28). Score of 0-7 has no clinically significant insomnia, 8-14 subthreshold insomnia, 15-21 clinical insomnia - moderate severity and 22-28 clinical insomnia - severe.

Decrease in prescription pain medication use. Measured by recording initial and changes in prescription medication names, dose and frequency

Decrease in other no-pain prescription medications. Measured by recording initial and changes in non-prescription medications names, dose and frequency

Hamilton Health Sciences Corporation

Medical Director

Musculoskeletal Diseases

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Sclerosis

Syndrome

Muscle Cramp

Spasm

Epilepsy

Seizures

Lennox Gastaut Syndrome

Tuberous Sclerosis

Spasms, Infantile

Epilepsies, Myoclonic

Neurologic Manifestations

Hamartoma

Neoplasms, Multiple Primary

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Epilepsy, Generalized

Brain Diseases

Central Nervous System Diseases

Epileptic Syndromes

Dravet Syndrome

CDKL5 Deficiency Disorder

Lennox-Gastaut Syndrome

Tuberous Sclerosis Complex

West Syndrome

Pharmaceutical Solutions

The 52-week treatment period includes a fixed 2-week titration schedule followed by flexible dose optimization.

Day 1: 5 mg/kg/day (2.5 mg/kg twice daily (b.i.d.))

Day 8: 10 mg/kg/day (5 mg/kg b.i.d.)

Day 15 to Week 52: Flexible dosing based on the participant's observed efficacy, safety, and tolerability per the investigator's clinical judgement. Up to a maximum of 20 mg/kg/day (10 mg/kg b.i.d.) for LGS and DS or 25 mg/kg/day (12.5 mg/kg b.i.d.) for TSC, in maximum weekly increments of 5 mg/kg/day (≤ 2.5 mg/kg b.i.d.).

GWP42003-P

Clinical Trial Disclosure & Transparency

This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants \< 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet syndrome (DS).

The study duration will be up to approximately 62 weeks, including a 4-week screening/baseline period, a 52-week dose optimization treatment period (which includes a fixed 2-week titration period followed by flexible dose optimization), a 10-day taper period, and a safety follow-up period (4 weeks after the end-of-taper visit).

Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures

An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled Seizures

The CGIC/S is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores will be summed and the total will be reported. Higher scores indicate poor clinical outcome.

The Infant and Toddler Quality of Life Questionnaire Short Form 47 (ITQOL-47) was developed for use in infants and toddlers from 12-months-to-5 years of age and assesses levels of health and well-being. The caregiver will complete the assessment on an electronic device. For each concept, item responses are scored, summed, and transformed on a scale from 0 (worst health) to 100 (best health). Higher scores indicate better clinical outcome.

Treatment Responders are defined as participants with ≥ 50% reduction from baseline in caregiver-reported total countable seizures

This endpoint includes the following changes in percentage of seizures:

* \> 25% (increase);
* ≥ 0% to ≤ 25% (increase);
* \> -25% to \< 0% (reduction);
* \> -50% to ≤ -25% (reduction);
* \> -75% to ≤ -50% (reduction);
* ≤ -75% (reduction).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RCT of CBD for Anxiety in Advanced Breast Cancer	NCT04482244	Advanced Breast... Anxiety CBD	Cannabidiol Placebo	18 Years -	Dana-Farber Cancer Institute
Carfilzomib In Combination With Bendamustine And Dexamethasone In Refractory Or Relapsed Multiple Myeloma	NCT02056756	Multiple Myelom...	Carfilzomib	18 Years -	Stichting European Myeloma Network
CANnabinoids in Pediatric ONCology	NCT05754840	Childhood Cance... Cancer	MPL-001 MPL-005 MPL-009	4 Years - 18 Years	University of Manitoba
CANnabinoids in Pediatric ONCology	NCT05754840	Childhood Cance... Cancer	MPL-001 MPL-005 MPL-009	4 Years - 18 Years	University of Manitoba
Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi	NCT01041612	Cancer of Bile ... Pancreatic Canc...	PTFE Covered Co... PTFE Covered Co...	18 Years -	Taewoong Medical Co., Ltd.
CANnabinoids in Pediatric ONCology	NCT05754840	Childhood Cance... Cancer	MPL-001 MPL-005 MPL-009	4 Years - 18 Years	University of Manitoba
Cannabis Oil for Chronic Non-Cancer Pain Treatment	NCT03635593	Chronic Non-can...	CBD CBD+THC Placebo	26 Years -	Hamilton Health Sciences Corporation
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures	NCT04485104	Seizure in Part... Seizure in Part... Seizure in Part...	GWP42003-P	1 Month - 23 Months	Jazz Pharmaceuticals
An Observational Post-Marketing Safety Registry of Sativex®	NCT02073474	Multiple Sclero... Diabetes Cancer Neuropathic Pai...	Sativex®	-	Jazz Pharmaceuticals
RCT of CBD for Anxiety in Advanced Breast Cancer	NCT04482244	Advanced Breast... Anxiety CBD	Cannabidiol Placebo	18 Years -	Dana-Farber Cancer Institute
Study of the Glutaminase Inhibitor CB-839 in Solid Tumors	NCT02071862	Solid Tumors Triple-Negative... Non Small Cell ... Renal Cell Carc... Mesothelioma Fumarate Hydrat... Succinate Dehyd... Succinate Dehyd... Tumors Harborin... Tumors Harborin...	CB-839 Pac-CB CBE CB-Erl CBD CB-Cabo	18 Years -	Calithera Biosciences, Inc

Spots Global Cancer Trial Database for cbd

Every month we try and update this database with for cbd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cbd

Every month we try and update this database with for cbd cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cbd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.