Understanding the Late Effects of Surviving a Pediatric Brain Tumor

Study Purpose

The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 6 Years - 16 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Children Treated for Posterior Fossa Tumors:
  • - As per medical record or clinical report, successfully completed all medical treatment for either an M0 posterior fossa medulloblastoma without dissemination or posterior fossa low-grade astrocytoma without relapse or evidence of residual disease.
  • - For medulloblastoma survivors only: Previously treated with gross total resection (GTR), craniospinal irradiation with conformal posterior fossa boost radiotherapy (CSI + Boost) and chemotherapy - For low grade astrocytoma survivors only: Previously treated with gross total resection ONLY (no chemotherapy or radiotherapy).
  • - As per medical record or clinician report, between 1-10 years post completion of their medical treatment for their posterior fossa brain tumor.
  • - Subject is between the ages of 6 through 16 years at time of consent.
  • - As per medical record or parent report, subject is able to tolerate an MRI without sedation.
Healthy Control Participants:
  • - No major medical illness, as determined by medical interview by study physician.
  • - As per parent report, subject is between the ages of 6 through 16 years at time of consent.
  • - As per parent report, subject is able to tolerate an MRI without sedation.

Exclusion Criteria:

All Participants:
  • - Full Scale IQ as documented to be below a standard score of <70 based upon the study IQ assessment completed after consent.
  • - As per self or parent report, completed any portion of the neuropsychological battery used in this study within the last year.
  • - MRI contraindications (e.g., implanted ferromagnetic devices, claustrophobia) as per radiology clinical operating procedures.
  • - As per self or parent report or medical record, currently taking medications that have CNS effects (i.e., antidepressants, neuroleptics, anti-seizure medications, drugs that affect blood pressure or heart rate, alpha-agonists, adrenergic blockers, lithium, sedating antihistamines, and some medications for the treatment of asthma).
  • - As per self or parent report, non-fluency in English language as demonstrated by current educational placement in a non-English-speaking classroom setting.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03208387
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Stephen Sands, PsyD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Tumor, Pediatric Brain Tumor, Pediatric Cancer
Study Website: View Trial Website
Arms & Interventions

Arms

: Children Medulloblastoma Survivors

Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa

: Children Astrocytoma Survivors

Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation.

: Age-Matched Healthy Children Controls

Interventions

Diagnostic Test: - Diffusion tensor imaging (DTI)

DTI quantifies the degree to which water diffuses in different directions through a given brain region. The use of DTI as an in vivo index of the integrity of white matter has been applied to many disease states using several proprietary and open-source software programs (e.g. FSL 5.0). DTI tractography, employed via toolboxes such as Probtrackx within the FSL 5.0, allows the identification of white matter tracts connecting cortical and subcortical regions of interest. Furthermore, structural connectivity as measured with DTI does not duplicate functional connectivity as measure with rs-fcMRI, but rather provides complimentary perspectives.

Diagnostic Test: - Resting state functional connectivity MRI (rs-fcMRI)

rs-fcMRI is a relatively new neuroimaging technique that has been applied to studying multiple clinical populations including ADHD, schizophrenia, major depressive disorder, and other neurological disorders. The approach exploits measurement of changes in brain blood oxygenation (BOLD) as is employed in task based functional MRI (measuring changes in focal cortical vascular oxygenation when engaged in a defined task, e.g. motor movement). Neuroimaging data will be collected as soon as possible (can be the same day), for up to 6 weeks.

Behavioral: - Wechsler Intelligence Scale for Children - 5th edition (WISC-V)

Will gather IQ data and is the gold standard for IQ assessment for those between the ages of 6:0 and 16:11 years.

Behavioral: - California Verbal Learning Test (CVLT-C)

Validated measure of verbal learning and memory for those between the ages of 5:0 and 16:11.

Behavioral: - Beery Test of Visual Motor Integration 6th edition

Measure designed to assess visual-motor functioning of subjects between the ages of 2-99 years old by copying designs using paper and pencil.

Behavioral: - Grooved Pegboard

This is a standard assessment of fine motor functioning and dexterity by asking the subject to place metal pegs into holes on a board.

Behavioral: - PedsQL Multidimensional Fatigue Scale

Designed to measure fatigue in pediatric patients (ages 5-17 years) and is comprised of the General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items) and Cognitive Fatigue Scale (6 items).

Diagnostic Test: - MRI

Images will be acquired on a 3.0 Tesla MRI scanner at each of the four study sites. At MSK, resting state fMRI data will be obtained using a 3T GE scanner with an 8-channel head coil (Discovery 750w DV25)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Columbia University, New York, New York

Status

Completed

Address

Columbia University

New York, New York, 10032

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Stephen Sands, PsyD

sandss@mskcc.org

646-888-0023

Dallas, Texas

Status

Recruiting

Address

University of Texas Southwestern Medical Center

Dallas, Texas, 75235

Site Contact

Nancy Rollins, MD

sandss@mskcc.org

214-730-5437

Seattle Children's Hospital, Seattle, Washington

Status

Recruiting

Address

Seattle Children's Hospital

Seattle, Washington, 98105

Site Contact

Dennis W Shaw, MD

sandss@mskcc.org

206-987-2134

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