RECRUITING

Neuroblastoma Maintenance Therapy Trial

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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

Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter, study for patients with neuroblastoma in remission. In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are in remission as a strategy to prevent recurrence.

Official Title

NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

Quick Facts

Study Start:2016-02

Study Completion:2033-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02679144

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:1 Year to 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* All patients must have a pathologically confirmed diagnosis of neuroblastoma, \< 30.99 years of age and classified as high risk at the time of diagnosis. Exception: patients who are initially diagnosed as non-high-risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma are also eligible. * All patients must be in complete remission (CR): 1. No evidence of residual disease on scan 2. No evidence of disease metastatic to bone marrow. * Specific Criteria by Stratum: * Pre-enrollment tumor survey: Prior to enrollment on this study, a determination of mandatory disease staging must be performed: * Tumor imaging studies including * Bilateral bone marrow aspirates and biopsy * This disease assessment is required for eligibility and preferably should be done within 2 weeks prior to enrollment, but must be done within a maximum of 4 weeks before enrollment. * Timing from prior therapy: * Patients must have a Lansky or Karnofsky Performance Scale score of \> 50% and patients must have a life expectancy of ≥ 2 months. * All clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated below. * Patients must have adequate organ functions at the time of registration: * Hematological: Total absolute phagocyte count ≥1000/μL * Liver: Subjects must have adequate liver function * Renal: Adequate renal function * Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding. * Written informed consent in accordance with institutional and FDA (food and drug administration) guidelines must be obtained from all subjects (or patients' legal representative).	* BSA (Body Surface Area) of \<0.25 m2. * Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation. * Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from hematological and bone marrow suppression effects of prior chemotherapy. * Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator. * Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.

Inclusion Criteria

Exclusion Criteria

* All patients must have a pathologically confirmed diagnosis of neuroblastoma, \< 30.99 years of age and classified as high risk at the time of diagnosis. Exception: patients who are initially diagnosed as non-high-risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma are also eligible.
* All patients must be in complete remission (CR):
1. No evidence of residual disease on scan
2. No evidence of disease metastatic to bone marrow.
* Specific Criteria by Stratum:
* Pre-enrollment tumor survey: Prior to enrollment on this study, a determination of mandatory disease staging must be performed:
* Tumor imaging studies including
* Bilateral bone marrow aspirates and biopsy
* This disease assessment is required for eligibility and preferably should be done within 2 weeks prior to enrollment, but must be done within a maximum of 4 weeks before enrollment.
* Timing from prior therapy:
* Patients must have a Lansky or Karnofsky Performance Scale score of \> 50% and patients must have a life expectancy of ≥ 2 months.
* All clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated below.
* Patients must have adequate organ functions at the time of registration:
* Hematological: Total absolute phagocyte count ≥1000/μL
* Liver: Subjects must have adequate liver function
* Renal: Adequate renal function
* Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
* Written informed consent in accordance with institutional and FDA (food and drug administration) guidelines must be obtained from all subjects (or patients' legal representative).

* BSA (Body Surface Area) of \<0.25 m2.
* Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
* Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from hematological and bone marrow suppression effects of prior chemotherapy.
* Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
* Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.

Contacts and Locations

Study Contact

BCC Enroll

CONTACT

7175310003

BCCEnroll@pennstatehealth.psu.edu

Principal Investigator

Giselle Sholler, MD

STUDY_CHAIR

Beat Childhood Cancer at Atrium Health

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

Rocky Mountain Pediatric Hematology

Denver, Colorado

United States

Connecticut Children's Hospital

Hartford, Connecticut, 06106

United States

University of Florida

Gainesville, Florida, 32611

United States

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

United States

All Children's Hospital Johns Hopkins Medicine

Saint Petersburg, Florida, 33701

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

Rebecca McFall

Chicago, Illinois

United States

Kentucky Children's Hospital

Lexington, Kentucky

United States

University of Louisville

Louisville, Kentucky

United States

Tufts Medical Center

Boston, Massachusetts, 02111

United States

University of Massachusetts Medical School Worcester

Worcester, Massachusetts

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

Gina Martin

Saint Louis, Missouri, 63104

United States

Hackensack University Medical Center

Hackensack, New Jersey

United States

New York University

New York, New York

United States

Levine Children's Hospital

Charlotte, North Carolina, 28204

United States

Duke University

Durham, North Carolina

United States

Cleveland Clinic Children's

Cleveland, Ohio

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

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

Hasbro Children's Hospital

Providence, Rhode Island

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Monroe Carrell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232

United States

Dell Children's Blood and Cancer Center

Austin, Texas, 78723

United States

Children's Medical Center

Dallas, Texas, 75235

United States

Texas Children's Cancer and Hematology Centers

Houston, Texas, 77030

United States

Primary Children's Hospital

Salt Lake City, Utah, 84113

United States

Children's Hospital of The King's Daughters

Norfolk, Virginia

United States

Virginia Commonwealth University

Richmond, Virginia

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Giselle Sholler

Giselle Sholler, MD, STUDY_CHAIR, Beat Childhood Cancer at Atrium Health

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 Date2016-02

Study Completion Date2033-02

Study Record Updates

Study Start Date2016-02

Study Completion Date2033-02

Terms related to this study

Additional Relevant MeSH Terms

Neuroblastoma