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Promising drug may stop deadly childhood cancer's return

NCT ID NCT02679144

Disease control Sponsor: Giselle Sholler Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests an oral drug called DFMO in children and young adults with high-risk neuroblastoma who are currently in remission. The goal is to see if taking DFMO for two years can prevent the cancer from coming back. The trial involves 441 participants and focuses on safety and how long they stay cancer-free.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 441 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2016

Expected to finish

Feb 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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: Stratum 1/1B: All patients must have completed standard upfront therapy that replicates treatment which patients who were enrolled on ANBL0032 received, including: intensive induction chemotherapy and (if feasible) resection of primary tumor, followed by: consolidation with high-dose chemotherapy with stem cell transplant and radiotherapy, followed by: immunotherapy with Ch14.18/IL-2/GM-CSF (dinutuximab) and retinoic acid;. All subjects on Stratum 1/B must have also met the following criteria: • A pre-transplant disease status evaluation that met International Neuroblastoma Response Criteria (INRC) for CR (complete response), VGPR (very good partial response), or PR (partial response) for primary site, soft tissue metastases and bone metastases. Patients who meet those criteria must also meet the protocol-specified criteria for bone marrow response prior to transplant as outlined below: No more than 10% tumor involvement (based on total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy. Stratum 2: Neuroblastoma that is in first complete remission following standard upfront therapy different from that described for Stratum 1. Stratum 3: Neuroblastoma that failed to have a response of at least PR following induction chemotherapy and surgical resection of the primary tumor, but that has achieved CR following additional therapy. Stratum 4: Patients who have achieved a second or subsequent CR following relapse(s). * 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: Stratum 1/1B: Enrollment no later than 60 days after completion of upfront therapy, (last dose of cis-retinoic acid) with a maximum of 6 cycles of cis-retinoic acid maintenance therapy. Stratum 2, 3 and 4: Enrollment no later than 60 days from last dose of the most recent 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). Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

neuroblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neuroblastoma

Contacts and locations

Locations

  • Advocate Aurora Research Institute

    Chicago, Illinois, 60453, United States

  • Alberta Children's Hospital

    Calgary, Alberta, AB T3B 6A8, Canada

  • All Children's Hospital Johns Hopkins Medicine

    St. Petersburg, Florida, 33701, United States

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806, United States

  • Augusta University Health

    Augusta, Georgia, 30912, United States

  • CHUQ

    Québec, Quebec, QC G1V 4W6, Canada

  • CancerCare Manitoba

    Winnipeg, Manitoba, MB R3E 0V9, Canada

  • Cardinal Glennon Children's Medical Center

    St Louis, Missouri, 63104, United States

  • Children's Hospital and Clinics of Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507, United States

  • Children's Medical Center

    Dallas, Texas, 75235, United States

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108, United States

  • Cleveland Clinic Children's

    Cleveland, Ohio, 44106, United States

  • Connecticut Children's Hospital

    Hartford, Connecticut, 06106, United States

  • Dell Children's Blood and Cancer Center

    Austin, Texas, 78723, United States

  • Duke University

    Durham, North Carolina, 27708, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hasbro Children's Hospital

    Providence, Rhode Island, 02903, United States

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503, United States

  • Janesway Children's Health and Rehabilitation Centre

    St. John's, Newfoundland and Labrador, NL A1B 3V6, Canada

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96813, United States

  • Kentucky Children's Hospital

    Lexington, Kentucky, 40536, United States

  • Levine Children's Hospital

    Charlotte, North Carolina, 28204, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, 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

  • Montreal Children's Hospital

    Montreal, Quebec, QC H4A 3H9, Canada

  • NYU Langone Health Hassenfeld Children's Hospital

    New York, New York, 10016, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine

    Louisville, Kentucky, 40202, United States

  • Penn State Milton S. Hershey Medical Center and Children's Hospital

    Hershey, Pennsylvania, 17033, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Rady Children's Hospital

    San Diego, California, 92123, United States

  • Randall Children's Hospital

    Portland, Oregon, 97227, United States

  • Rocky Mountain Pediatric Hematology

    Denver, Colorado, 80205, United States

  • St. Joseph's Children's Hospital

    Tampa, Florida, 33614, United States

  • St. Lukes

    Boise, Idaho, 83712, United States

  • Texas Children's Cancer and Hematology Centers

    Houston, Texas, 77030, United States

  • The Children's Hospital at Montefiore

    The Bronx, New York, 10467, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UCSF Benioff Children's Hospital Oakland-

    Oakland, California, 94609, United States

  • UHC Sainte-Justine

    Montreal, Quebec, QC H3S 2G4, Canada

  • University of Alabama, Children's of Alabama

    Birmingham, Alabama, 35233, United States

  • University of Florida

    Gainesville, Florida, 32611, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23284, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.