Medical Marijuana in the Pediatric Central Nervous System Tumor Population

• ClinicalTrials.gov Identifier: NCT03052738
• Recruitment Status: Active, not recruiting
• First Posted: February 14, 2017
• Last Update Posted: November 10, 2021
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

Brief Summary:

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).

Condition or disease
Central Nervous System Tumor; Brain Tumor; Spinal Tumor

Detailed Description:

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 Design

• Study Type: Observational
• Actual Enrollment: 19 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
• Actual Primary Completion Date: June 30, 2020
• Estimated Study Completion Date: June 30, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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

Peripheral Blood

Eligibility Criteria

• 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

Study Population

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.

Criteria

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

Contacts and Locations

Locations

United States, Colorado

Chilsdren's Hospital Colorado

Aurora, Colorado, United States, 80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

• Principal Investigator: Nicholas K Foreman, MD; University of Colorado, Denver

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03052738
• Other Study ID Numbers: 15-0404.cc
• First Posted: February 14, 2017
• Last Update Posted: November 10, 2021
• Last Verified: November 2021

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

Keywords provided by University of Colorado, Denver:

central nervous system (brain or spinal) tumor

Additional relevant MeSH terms:

Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Spinal Cord Neoplasms; Spinal Neoplasms; Neoplasms by Site; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Bone Neoplasms; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases