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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
  Purpose
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
Central Nervous System Tumor Brain Tumor Spinal Tumor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medical Marijuana in the Pediatric Central Nervous System Tumor Population

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 150
Actual Study Start Date: January 15, 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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. 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.

  Eligibility

Information from the National Library of Medicine

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

  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Kathleen Dorris, MD 720-777-8314 kathleen.dorris@childrenscolorado.org
Contact: Jessica Channell, BA 720-777-8847 jessica.channell@childrenscolorado.org

Locations
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   
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     History of Changes
Other Study ID Numbers: 15-0404.cc
First Submitted: February 9, 2017
First Posted: February 14, 2017
Last Update Posted: October 2, 2017
Last Verified: September 2017
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
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases