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Polyamine Synthesis Inhibitor

DFMO for Neuroblastoma

Phase 2
Waitlist Available
Research Sponsored by Giselle Sholler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is designed to study the safety and efficacy of DFMO in preventing reoccurrence of neuroblastoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Peak Plasma Concentration (Cmax)
+3 more

Side effects data

From 2023 Phase 2 trial • 140 Patients • NCT02395666
10%
ALT elevation
8%
Neutrophil count decrease
7%
AST elevation
6%
Infection
6%
Hearing Loss
6%
Diarrhea
4%
Anemia
4%
Otitis Media
2%
Vomiting
1%
Fever
1%
Pain
1%
Hyponatremia
1%
Benign vascular lesion
1%
Hypotension
1%
hearing loss
1%
Fracture
1%
Influenza
1%
Bacteremia
1%
Obstruction
1%
Swelling of Eye
1%
Hypoglycemia
1%
Urticaria
1%
Constipation
1%
Respiratory Disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Study Subjects

Trial Design

1Treatment groups
Experimental Treatment
Group I: DFMO twice dailyExperimental Treatment1 Intervention
Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DFMO
2010
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

Giselle ShollerLead Sponsor
21 Previous Clinical Trials
2,063 Total Patients Enrolled
18 Trials studying Neuroblastoma
1,436 Patients Enrolled for Neuroblastoma
Giselle SaulnierShollerLead Sponsor
21 Previous Clinical Trials
2,076 Total Patients Enrolled
18 Trials studying Neuroblastoma
1,449 Patients Enrolled for Neuroblastoma
Wake Forest University Health SciencesLead Sponsor
1,230 Previous Clinical Trials
1,001,613 Total Patients Enrolled
19 Trials studying Neuroblastoma
1,506 Patients Enrolled for Neuroblastoma

Media Library

DFMO (Polyamine Synthesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02395666 — Phase 2
Neuroblastoma Research Study Groups: DFMO twice daily
Neuroblastoma Clinical Trial 2023: DFMO Highlights & Side Effects. Trial Name: NCT02395666 — Phase 2
DFMO (Polyamine Synthesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02395666 — Phase 2

Frequently Asked Questions

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

How many participants are currently involved in this research program?

"At the present time, this research project is not recruiting participants. Initially posted in March 2015 and last modified on April 20th 2022, it does not appear to be open for enrollment. If you're searching for other trials, 161 studies are enrolling patients with neuroblastoma while 11 more accept subjects being treated with DFMO."

Answered by AI

Could you provide an overview of past research endeavors that have utilized DFMO?

"First studied in 2013, the effects of DFMO have been monitored across 11 trials. Currently, a further 11 clinical studies are underway; many of these can be found in Minneapolis."

Answered by AI

How many Canadian sites are hosting this clinical trial?

"This clinical trial is operating in 24 places, with its primary 3 sites being Children's Hospital and Clinics on Minnesota in Minneapolis, Minnesota; Children's Mercy Hospitals and Clinics in Kansas City, Missouri; and Kapiolani Medical Center for Women and Children in Honolulu, Hawaii."

Answered by AI

Are individuals able to apply for this trial at present?

"Unfortunately, no longer are individuals being accepted into this clinical trial. It was initially posted on 1st March 2015 and has just been recently updated on 20th April 2022. However, there are still 161 studies seeking patients with neuroblastoma as well 11 trials for DFMO that need participants to participate in the research."

Answered by AI

Is this investigation the inaugural research of its type?

"Ever since 2013, DFMO has been the subject of medical research, with a first trial sponsored by Cancer Prevention Pharmaceuticals Inc. After these initial investigations involving 1340 participants that same year led to phase 3 drug approval. Nowadays there are 11 active clinical trials for this medication conducted in 699 cities and 12 countries around the world."

Answered by AI

Does the Food and Drug Administration recognize DFMO as a viable medical treatment?

"Our team has evaluated DFMO's safety according to the available data and assigned it a score of 2; while Phase 2 trials provide some evidence that this medicine is safe, there is no existing proof that it works."

Answered by AI
Recent research and studies
~14 spots leftby Mar 2025