RECRUITING

Pediatric Precision Laboratory Advanced Neuroblastoma Therapy

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A prospective open label, multicenter study to evaluate the feasibility and acute toxicity of using molecularly guided therapy in combination with standard therapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma.

Official Title

A Study Using Molecular Guided Therapy With Induction Chemotherapy Followed by a Randomized Controlled Trial of Standard Immunotherapy With or Without DFMO Followed by DFMO Maintenance for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Quick Facts

Study Start:2015-09
Study Completion:2035-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02559778

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BCC Enroll
CONTACT
7175310003
BCCEnroll@pennstatehealth.psu.edu

Principal Investigator

Giselle Sholler, MD
STUDY_CHAIR
Beat Childhood Cancer

Study Locations (Sites)

University of Alabama, Children's of Alabama
Birmingham, Alabama
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
United States
UCSF Benioff Children's Hospital Oakland-
Oakland, California
United States
Rady Children's Hospital
San Diego, California, 92123
United States
Connecticut Children's Hospital
Hartford, Connecticut, 06106
United States
Nicklaus Children's Miami
Miami, Florida
United States
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
United States
St. Joseph's Children's Hospital
Tampa, Florida, 33614
United States
Augusta University Health
Augusta, Georgia
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96813
United States
St. Lukes
Boise, Idaho
United States
Advocate Children's Medical Group
Chicago, Illinois
United States
University of Louisville
Louisville, Kentucky
United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
United States
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, 55404
United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
United States
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, 63104
United States
Hackensack University Medical Center
Hackensack, New Jersey
United States
Levine Children's Hospital
Charlotte, North Carolina, 28204
United States
Randall Children's Hospital
Portland, Oregon
United States
Penn State Milton S. Hershey Medical Center and Children's Hospital
Hershey, Pennsylvania, 17033
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Dell Children's Blood and Cancer Center
Austin, Texas, 78723
United States
Children's Medical Center
Dallas, Texas, 75235
United States
Children's Hospital of The King's Daughters
Norfolk, Virginia
United States

Collaborators and Investigators

Sponsor: Giselle Sholler

  • Giselle Sholler, MD, STUDY_CHAIR, Beat Childhood Cancer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-09
Study Completion Date2035-09

Study Record Updates

Study Start Date2015-09
Study Completion Date2035-09

Terms related to this study

Additional Relevant MeSH Terms

  • Neuroblastoma