Neuroblastoma Maintenance Therapy Trial

Sponsor: Giselle Sholler

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02679144

Provider View

This clinical trial is testing a medication called DFMO to see if it can help prevent neuroblastoma, a type of cancer, from coming back in patients who are currently in remission. Participants will take DFMO by mouth for 730 days.

Patient Parameters

Program Overview

The study is exploring the use of a drug called Difluoromethylornithine (DFMO) for patients with neuroblastoma who are in remission. The goal is to see if DFMO can help prevent the cancer from returning. Participants will take DFMO orally every day for 730 days. The study is open to patients with high-risk neuroblastoma who have completed their initial treatment and are currently cancer-free.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of neuroblastoma and be under 31 years old.
  • Classified as high-risk at diagnosis or have relapsed to high-risk neuroblastoma.
  • Must be in complete remission, meaning no signs of cancer on scans or in bone marrow.
  • Specific criteria based on treatment history:
    • Stratum 1/1B: Completed standard therapy similar to ANBL0032, including chemotherapy, surgery, stem cell transplant, radiotherapy, and immunotherapy.
    • Stratum 2: In first complete remission after different standard therapy.
    • Stratum 3: Achieved complete remission after additional therapy following initial treatment failure.
    • Stratum 4: Achieved a second or later complete remission after relapse.
  • Must undergo a tumor survey, including imaging and bone marrow tests, within 4 weeks before joining the study.
  • Must enroll within 60 days after completing previous therapy.
  • Must have a performance score above 50% and a life expectancy of at least 2 months.
  • Must have adequate organ function, including blood, liver, and kidneys.
  • Females of childbearing potential must have a negative pregnancy test and agree to use birth control.
  • Must provide written informed consent.

Exclusion Criteria

  • Body Surface Area (BSA) less than 0.25 m2.
  • Currently taking another investigational drug.
  • Currently receiving other cancer treatments.
  • Must have recovered from previous chemotherapy effects.
  • Have an uncontrolled infection.
  • Unable to comply with study safety monitoring requirements.

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