← Back to Search

Nonsteroidal Anti-inflammatory Drug (NSAID)

DFMO + Celecoxib + Cyclophosphamide + Topotecan for Neuroblastoma (DFMO Trial)

Phase 1

Waitlist Available

Research Sponsored by New Approaches to Neuroblastoma Therapy Consortium

Eligibility Criteria Checklist

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

Must have

All patients must have at least ONE site of evaluable disease

Patients must have adequate heart, kidney, liver and bone marrow function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 1 year

Awards & highlights

DFMO Trial Summary

This trial will study the effects of combining DFMO with celecoxib, cyclophosphamide, and topotecan. The goal is to find the highest dosage of DFMO that can be given without causing severe side effects, and to study the side effects seen at different dose levels.

Who is the study for?

This trial is for children and young adults aged 2-29 with high-risk neuroblastoma that's recurrent, progressive, or hasn't fully responded to standard treatment. Participants need evaluable disease but good heart, kidney, liver, and bone marrow function. They can't join if they have severe allergies to NSAIDs/aspirin/sulfonamides, are pregnant/breastfeeding without contraception use, have major organ issues or active infections.Check my eligibility

What is being tested?

The study tests different doses of DFMO (oral) combined with celecoxib (oral), cyclophosphamide (IV), and topotecan (IV) in patients with neuroblastoma. It aims to find the highest tolerable dose of DFMO without severe side effects and assess its impact on tumor size and specific gene changes related to treatment response.See study design

What are the potential side effects?

Potential side effects include those common to chemotherapy like nausea, hair loss, low blood cell counts leading to increased infection risk; plus possible stomach irritation from celecoxib. The severity may vary based on the DFMO dosage.

DFMO Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have at least one tumor that can be measured for treatment response.

Select...

My heart, kidneys, liver, and bone marrow are functioning well.

Select...

I am between 2 and 30 years old.

Select...

My neuroblastoma is high-risk and has not fully responded to standard treatments.

Select...

My bone marrow works well enough for me to join the study.

DFMO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year 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 adverse events as a measure of safety and tolerability.

Side effects data

From 2023 Phase 2 trial • 140 Patients • NCT02395666

10%

ALT elevation

Neutrophil count decrease

AST elevation

Infection

Hearing Loss

Diarrhea

Anemia

Otitis Media

Vomiting

Fever

Pain

Hyponatremia

Benign vascular lesion

Hypotension

hearing loss

Fracture

Influenza

Bacteremia

Obstruction

Swelling of Eye

Hypoglycemia

Urticaria

Constipation

Respiratory Disorder

100%

80%

60%

40%

20%

Study treatment Arm

All Study Subjects

DFMO Trial Design

1Treatment groups

Experimental Treatment

Group I: DFMO, Celecoxib, Cyclophosphamide & TopotecanExperimental Treatment4 Interventions

Reconstituted DFMO powder by mouth for 14 days and celecoxib capsule by mouth daily in each cycle. Cyclophosphamide and Topotecan IV on days 8-12 in cycle 1 and days 1-5 of cycles 2-17. Patients may continue for up to 17 cycles as long as therapy is tolerated (no DLT) and disease progression does not occur (SD or better). *Cycle 1 will include a 7 day lead-in with DFMO and celecoxib to deplete tumor polyamines.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DFMO

2010

Completed Phase 2

~220

Celecoxib

FDA approved

Cyclophosphamide

FDA approved

Topotecan

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

New Approaches to Neuroblastoma Therapy ConsortiumLead Sponsor

16 Previous Clinical Trials

1,604 Total Patients Enrolled

16 Trials studying Neuroblastoma

1,604 Patients Enrolled for Neuroblastoma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,123 Total Patients Enrolled

205 Trials studying Neuroblastoma

53,698 Patients Enrolled for Neuroblastoma

Michael Hogarty, MDStudy ChairChildren's Hospital of Philadelphia

2 Previous Clinical Trials

679 Total Patients Enrolled

2 Trials studying Neuroblastoma

679 Patients Enrolled for Neuroblastoma

Media Library

Celecoxib (Nonsteroidal Anti-inflammatory Drug (NSAID)) Clinical Trial Eligibility Overview. Trial Name: NCT02030964 — Phase 1

Neuroblastoma Research Study Groups: DFMO, Celecoxib, Cyclophosphamide & Topotecan

Neuroblastoma Clinical Trial 2023: Celecoxib Highlights & Side Effects. Trial Name: NCT02030964 — Phase 1

Celecoxib (Nonsteroidal Anti-inflammatory Drug (NSAID)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02030964 — Phase 1

Frequently Asked Questions

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

In what geographical areas is this clinical research being conducted?

"The investigation is being conducted from the Cook Children's Medical Center - Fort Worth in Fort Worth, Texas, together with other sites like the Children's Hospital Los Angeles in California and the Children's Hospital and Regional Medical Centre - Seattle. In total, there are 12 trial locations participating."

Answered by AI

For what medical conditions is DFMO frequently prescribed?

"Oftentimes, medical professionals prescribe DFMO as a treatment for multiple sclerosis. However, it has also been utilized to manage leukemia, myelocytic diseases, acute sarcomas and retinoblastomas."

Answered by AI

Is the age limit for this clinical experiment restricted to adults?

"This clinical trial is searching for participants aged between 2 and 30 years old. If the patient falls outside of this age range, there are 458 studies available to those under 18 and 718 trials open to seniors over 65."

Answered by AI

Who qualifies for participation in this clinical research endeavor?

"This clinical trial is accepting 30 patients aged 2 to 30 who have been diagnosed with neuroblastoma. In addition, those admitted must have at least one site of measurable disease, be in good bone marrow health and possess adequate cardiovascular, renal and hepatic function. Furthermore, applicants whose medical history includes other severe conditions will need approval from the principal investigator before they can enroll."

Answered by AI

Has the FDA granted authorization for using DFMO as a medication?

"Due to the lack of clinical evidence supporting DFMO's safety and efficacy, our team has given it a rating of 1 on the scale from 1 to 3."

Answered by AI

Is recruitment of participants still taking place for this experiment?

"Based on the information posted to clinicaltrials.gov, this trial is not actively enlisting individuals for participation at present. The research was initially published on December 1st 2013 and its contents were last updated on September 28th 2022. Despite it's current inactivity, there are still 1049 other trials that are open for recruitment of participants presently."

Answered by AI

Have any precedent experiments been conducted with DFMO?

"Presently, 888 clinical trials are live concerning DFMO with 174 in phase 3. Philadelphia is the epicentre for this research but there exists 31137 centres across the nation conducting related studies."

Answered by AI

How many participants are being incorporated into this trial?

"At present, no participants are being sought for this trial. It was first announced on December 1st 2013 and its most recent update occurred 28th September 2022. However, if you search for studies related to neuroblastoma there are presently 161 trials actively enrolling patients as well as 888 trials recruiting volunteers for DFMO treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan

2014. "N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02030964.

All > Neuroblastoma > Flu