We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Medical Marijuana in the Pediatric Central Nervous System Tumor Population

This study is currently recruiting participants.
Verified September 2017 by University of Colorado, Denver
Sponsor:
ClinicalTrials.gov Identifier:
NCT03052738
First Posted: February 14, 2017
Last Update Posted: October 2, 2017
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.
Information provided by (Responsible Party):
University of Colorado, Denver
February 9, 2017
February 14, 2017
October 2, 2017
January 15, 2016
December 2018   (Final data collection date for primary outcome measure)
Overall Quality of Life [ Time Frame: 1 year ]
quality-of-life scores as assessed by the validated PedsQL™ brain tumor (PedsQL™-BT) module
Same as current
Complete list of historical versions of study NCT03052738 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Medical Marijuana in the Pediatric Central Nervous System Tumor Population
Medical Marijuana in the Pediatric Central Nervous System Tumor Population
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. In particular, the influx of families from distant states seeking marijuana for their children, who often have unbeatable, advanced CNS tumors.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Peripheral Blood
Non-Probability Sample
This is a prospective observational cohort study evaluating the quality of life (QOL) of children with CNS tumors and their families who choose to self-medicate with marijuana-derived products while undergoing treatment at CHCO.
  • Central Nervous System Tumor
  • Brain Tumor
  • Spinal Tumor
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2018
December 2018   (Final data collection date for primary outcome measure)

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. Use (or planned use) of synthetic marijuana products as sole cannabinoid therapy

Sexes Eligible for Study: All
2 Years to 18 Years   (Child, Adult)
No
Contact: Kathleen Dorris, MD 720-777-8314 kathleen.dorris@childrenscolorado.org
Contact: Jessica Channell, BA 720-777-8847 jessica.channell@childrenscolorado.org
United States
 
 
NCT03052738
15-0404.cc
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Nicholas K Foreman, MD University of Colorado, Denver
University of Colorado, Denver
September 2017