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DFMO Maintenance Therapy for Neuroblastoma (NMTT Trial)

Phase 2

Recruiting

Research Sponsored by Giselle Sholler

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Patients must have a Lansky or Karnofsky Performance Scale score of > 50% and patients must have a life expectancy of ≥ 2 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

NMTT Trial Summary

This trial will use DFMO to try and prevent neuroblastoma recurrence in high risk patients who are in remission.

Who is the study for?

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.Check my eligibility

What is being tested?

The trial tests DFMO as an oral maintenance therapy for preventing neuroblastoma recurrence. Participants will take DFMO daily for two years at doses adjusted by body surface area. The study includes multiple patient groups based on their previous response to standard therapies.See study design

What are the potential side effects?

While the description doesn't specify side effects of DFMO directly, potential side effects may include hearing loss and mild blood disorders since it's being tested as a cancer drug; however individual experiences can vary.

NMTT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most activities and am expected to live for at least 2 more months.

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My scans show no signs of cancer, and my bone marrow is clear.

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I have had cancer come back but am now in remission again.

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My neuroblastoma responded well to treatment before a transplant, with less than 10% cancer in my bone marrow.

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My neuroblastoma is in its first complete remission after initial standard treatment.

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I've completed the specific treatment steps for my cancer as outlined, including chemotherapy, surgery, stem cell transplant, radiotherapy, and immunotherapy.

NMTT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with event free survival (EFS) during study.

Secondary outcome measures

Area under the plasma concentration versus time curve (AUC)

Length of time that participants experience Overall Survival (OS)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

+3 more

NMTT Trial Design

1Treatment groups

Experimental Treatment

Group I: Difluoromethylornithine (DFMO)Experimental Treatment1 Intervention

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.

0 / 7Eligibility criteria met

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Who is running the clinical trial?

Giselle ShollerLead Sponsor

21 Previous Clinical Trials

1,947 Total Patients Enrolled

18 Trials studying Neuroblastoma

1,320 Patients Enrolled for Neuroblastoma

Giselle SaulnierShollerLead Sponsor

21 Previous Clinical Trials

1,960 Total Patients Enrolled

18 Trials studying Neuroblastoma

1,333 Patients Enrolled for Neuroblastoma

Wake Forest University Health SciencesLead Sponsor

1,242 Previous Clinical Trials

1,004,009 Total Patients Enrolled

19 Trials studying Neuroblastoma

1,390 Patients Enrolled for Neuroblastoma

Media Library

Difluoromethylornithine (DFMO) Clinical Trial Eligibility Overview. Trial Name: NCT02679144 — Phase 2

Neuroblastoma Research Study Groups: Difluoromethylornithine (DFMO)

Neuroblastoma Clinical Trial 2023: Difluoromethylornithine (DFMO) Highlights & Side Effects. Trial Name: NCT02679144 — Phase 2

Difluoromethylornithine (DFMO) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02679144 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is patient recruitment still open for this research project?

"Yes, this study is looking for volunteers and has been since February 1st, 2016. The most recent update to the posting was on June 23rd, 2022."

Answered by AI

Are there any other ongoing or completed research projects that have used Difluoromethylornithine?

"The first study of difluoromethylornithine (DFMO) was completed in 2013 by Lake Norman Hematology Oncology Specialists-Mooresville. To date, there have been 10 total clinical trials with 11 more ongoing. The majority of these live studies are based out of Louisville, Kentucky."

Answered by AI

Does this research include senior citizens as participants?

"According to the guidelines for this clinical trial, any person aged 1 year or older but not yet 30 years old may participate."

Answered by AI

Is this a novel clinical trial?

"Difluoromethylornithine (DFMO) has been the subject of 11 clinical trials over the last 8 years. The first one was completed in 2013 and involved 1340 patients. It reached Phase 3 approval. 10 more have been conducted since then, with active studies present in 699 cities across 12 countries."

Answered by AI

How many subjects are being trialed in this experiment?

"Yes, the information available on clinicaltrials.gov verifies that this research is actively seeking participants. The trial was established on February 1st, 2016 and has had 41 different sites since its inception. As of right now, 258 patients are needed for the study's completion."

Answered by AI

Could you explain the possible dangers of Difluoromethylornithine (DFMO)?

"Difluoromethylornithine (DFMO) is a medication that, according to our team's research, carries a safety rating of 2. This is due to the lack of available data on efficacy despite some evidence pointing to it being a safe drug."

Answered by AI

Is this study also being conducted in any Canadian hospitals?

"This trial is currently taking place at 41 different hospitals and medical research facilities. Some of these locations include the University of Louisville, Cleveland Clinic Children's in Cleveland, Helen DeVos Children's Hospital in Grand Rapids, among others."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neuroblastoma Maintenance Therapy Trial

Giselle Sholler 2016. "Neuroblastoma Maintenance Therapy Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02679144.

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