Medical Marijuana in the Pediatric Central Nervous System Tumor Population
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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: NCT03052738 |
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Recruitment Status :
Recruiting
First Posted : February 14, 2017
Last Update Posted : December 3, 2018
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| Condition or disease |
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| Central Nervous System Tumor Brain Tumor Spinal Tumor |
Children's Hospital Colorado (CHCO) Center for Cancer and Blood Disorders (CCBD) is a national leader in pediatric cancer therapy. The CHCO Neuro-Oncology program treats more that 90% of Coloradan children with Central Nervous System (CNS) tumors and a large percentage of children with CNS tumors from the surrounding five states. Due to advances in therapy, approximately two-thirds of children with CNS tumors treated at CHCO will be cured. Although medical marijuana has been legal for more than a decade in Colorado, the publicity around the more recent legalization for general adult use, increasing literature, and anecdotal reports of patients with terminal CNS tumors cured with medical marijuana, have prompted a recent increase in interest of current CHCO patients and their families. There has been an influx of pediatric cancer patients and their families moving to Colorado to obtain these marijuana-based products to self-medicate.
The Investigators will administer PedsQLTM questionnaires and diaries to gather data regarding use practices, method of delivery, strain used, dosing and frequency, and family financial impact on all enrolled patients. The Investigators will also collect peripheral blood samples to evaluate for evidence of immuno-modulation by cannabinoids in patients who may already be immunocompromised and to assess blood cannabinoid levels.
This study will provide novel exploratory data regarding use patterns, impact on families and resources, and potential clinical benefits and harms associated with the growing marijuana use in the pediatric neuro-oncology population. Such information may guide future children afflicted with CNS tumors and their families to make decisions about whether to pursue cannabinoid treatment.
| Study Type : | Observational |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Medical Marijuana in the Pediatric Central Nervous System Tumor Population |
| Actual Study Start Date : | January 15, 2016 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | December 2019 |
- Overall Quality of Life [ Time Frame: 1 year ]quality-of-life scores as assessed by the validated PedsQL™ brain tumor (PedsQL™-BT) module
Biospecimen Retention: Samples Without DNA
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.
| Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age > 2 years and < 18 years at the time of study enrollment.
- Parents/legal guardian(s) that will be completing the questionnaires must sign consent. There are no age parameters for parent/legal guardians' participation on study.
- Patients must have a diagnosis of central nervous system (brain or spinal) tumor
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Patients must be ONE of the following:
- Undergoing disease-directed therapy or disease surveillance as prescribed by the Pediatric Neuro-Oncology physicians at CHCO
- Planning to transfer medical care to Pediatric Neuro-Oncology physicians at CHCO from outside facilities
- Receiving palliative care services that are managed in conjunction with physicians at CHCO
- Interest in marijuana use has been discussed by the patient or parents.
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Patient has not used any marijuana products or synthetics in the last 14 days (a washout period of 14 days is permitted for those interested in participating on this study)
- An exception to this rule is if patients took their first dose within 72 hours of signing consent. These patients will be eligible for study without going through a washout period.
Exclusion Criteria:
- Does not meet inclusion criteria
- Use (or planned use) of synthetic marijuana products as sole cannabinoid therapy
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): NCT03052738
| Contact: Kathleen Dorris, MD | 720-777-8314 | kathleen.dorris@childrenscolorado.org | |
| Contact: Jessica Channell, BA | 720-777-8847 | jessica.channell@childrenscolorado.org |
| United States, Colorado | |
| Chilsdren's Hospital Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Kathleen Dorris, MD kathleen.dorris@childrenscolorado.org | |
| Contact: Jessica Channell, BA jessica.channell@childrenscolorado.org | |
| Principal Investigator: | Nicholas K Foreman, MD | University of Colorado, Denver |
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT03052738 History of Changes |
| Other Study ID Numbers: |
15-0404.cc |
| First Posted: | February 14, 2017 Key Record Dates |
| Last Update Posted: | December 3, 2018 |
| Last Verified: | November 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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central nervous system (brain or spinal) tumor |
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Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases |