DFMO Maintenance Therapy for Neuroblastoma
(NMTT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called DFMO in patients with high-risk neuroblastoma who are in remission. The goal is to prevent the cancer from returning by stopping an enzyme that cancer cells need to grow. DFMO was initially developed as a cancer therapeutic agent but gained renewed interest as a preventive agent after showing effectiveness in inhibiting cancer development in rodent models.
Will I have to stop taking my current medications?
The trial requires that participants stop taking other anticancer agents before joining. The protocol does not specify about other medications, so it's best to discuss your current medications with the study team.
Is DFMO safe for use in humans?
How does DFMO maintenance therapy for neuroblastoma differ from other treatments?
DFMO (2-difluoromethylornithine) is unique because it targets polyamine levels, which are compounds involved in cell growth, and has shown effectiveness in reducing tumor polyamine levels without severe toxicities. This approach is different from traditional chemotherapy, which often targets DNA synthesis or cell division directly.678910
What data supports the effectiveness of the drug DFMO for treating neuroblastoma?
Who Is on the Research Team?
Giselle Sholler, MD
Principal Investigator
Beat Childhood Cancer at Atrium Health
Are You a Good Fit for This Trial?
This trial is for high-risk neuroblastoma patients under 30.99 years old in remission after intensive treatment, including chemotherapy, surgery, stem cell transplant, radiotherapy, immunotherapy with dinutuximab and retinoic acid. They must have no residual disease or bone marrow involvement over 10%, be within a specific time frame post-treatment, agree to birth control if applicable, and not be on other investigational drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 730 days of oral difluoromethylornithine (DFMO) to prevent recurrence of neuroblastoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Difluoromethylornithine (DFMO)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Giselle Sholler
Lead Sponsor
Giselle SaulnierSholler
Lead Sponsor
Wake Forest University Health Sciences
Lead Sponsor
Beat NB Cancer Foundation
Collaborator
Team Parker for Life
Collaborator