Medical Marijuana in the Pediatric Central Nervous System Tumor Population



Status:Recruiting
Conditions:Brain Cancer, Brain Cancer, Orthopedic
Therapuetic Areas:Oncology, Orthopedics / Podiatry
Healthy:No
Age Range:2 - 18
Updated:12/5/2018
Start Date:January 15, 2016
End Date:December 2019
Contact:Kathleen Dorris, MD
Email:kathleen.dorris@childrenscolorado.org
Phone:720-777-8314

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This study proposes to do a prospective observational cohort study evaluating the quality of
life (QOL) of children with Central Nervous System (CNS) tumors and their families who choose
to self-medicate with marijuana-derived products while undergoing treatment at Children's
Hospital Colorado (CHCO).

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.

Inclusion Criteria:

1. Age > 2 years and < 18 years at the time of study enrollment.

2. 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.

3. Patients must have a diagnosis of central nervous system (brain or spinal) tumor

4. 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

5. Interest in marijuana use has been discussed by the patient or parents.

6. 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)

1. 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:

1. Does not meet inclusion criteria

2. Use (or planned use) of synthetic marijuana products as sole cannabinoid therapy
We found this trial at
1
site
13123 East 16th Avenue
Aurora, Colorado 80045
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from
Aurora, CO
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