All > Hawaii > Honolulu

Eflornithine for Neuroblastoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Dell Children's Blood and Cancer Center, Austin, TXNeuroblastomaEflornithine - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the combination of DFMO and etoposide for subjects with relapsed/refractory neuroblastoma.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Cyclophosphamide
1
Magrolimab
1
Lorlatinib

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 2 years plus 5 years follow up

2 years
Determine the Overall Response Rate (ORR) of Participants using INSS Response Evaluation Criteria.
Year 2
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Year 5
Number of participants with event free survival (EFS) during study
7 years
Length of time that participants experience Overall Survival (OS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Cyclophosphamide
1
Magrolimab
1
Lorlatinib

Side Effects for

Eflornithine Plus Sulindac
21%nausea
14%abdominal pain
14%upper respiratory tract infection
14%headache
13%gastroenteritis
13%diarrhoea
13%abdominal pain upper
13%rectal haemorrhage
11%vomiting
11%rash
11%haematochezia
11%nasopharyngitis
9%back pain
9%flatulence
9%influenza like illness
9%oropharyngeal pain
7%fatigue
7%myalgia
7%influenza
7%dizziness
7%sinusitis
7%arthralgia
5%pouchitis
5%cough
5%pruritus
5%gastritis erosive
5%dry skin
5%constipation
5%small bowel obstruction
5%gastroenteritis viral
5%neck pain
5%urticaria
4%anxiety
4%dyspepsia
4%abdominal distension
4%weight increased
4%decreased appetite
4%alopecia
4%small intestinal obstruction
4%urinary tract infection
2%bursitis
2%contusion
2%bronchitis
2%nasal congestion
2%wound dehiscence
2%nephritis
2%hyperglycaemia
2%depression
2%renal failure acute
2%ileus
2%seroma
2%pancreatitis acute
2%lung adenocarcinoma
2%insomnia
2%inguinal hernia
2%ear pain
2%pulmonary mass
2%psychotic disorder
2%seasonal allergy
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT01483144) in the Eflornithine Plus Sulindac ARM group. Side effects include: nausea with 21%, abdominal pain with 14%, upper respiratory tract infection with 14%, headache with 14%, gastroenteritis with 13%.

Trial Design

1 Treatment Group

Eflornithine (DFMO)
1 of 1

Experimental Treatment

131 Total Participants · 1 Treatment Group

Primary Treatment: Eflornithine · No Placebo Group · Phase 2

Eflornithine (DFMO)
Drug
Experimental Group · 1 Intervention: Eflornithine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eflornithine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years plus 5 years follow up

Who is running the clinical trial?

Giselle SaulnierShollerLead Sponsor
21 Previous Clinical Trials
2,085 Total Patients Enrolled
18 Trials studying Neuroblastoma
1,458 Patients Enrolled for Neuroblastoma
Team Parker for LifeUNKNOWN
2 Previous Clinical Trials
758 Total Patients Enrolled
2 Trials studying Neuroblastoma
758 Patients Enrolled for Neuroblastoma
Wake Forest University Health SciencesLead Sponsor
1,144 Previous Clinical Trials
1,140,302 Total Patients Enrolled
19 Trials studying Neuroblastoma
1,515 Patients Enrolled for Neuroblastoma
K C Pharmaceuticals Inc.Industry Sponsor
4 Previous Clinical Trials
656 Total Patients Enrolled
4 Trials studying Neuroblastoma
656 Patients Enrolled for Neuroblastoma
Beat NB Cancer FoundationOTHER
5 Previous Clinical Trials
1,003 Total Patients Enrolled
5 Trials studying Neuroblastoma
1,003 Patients Enrolled for Neuroblastoma
Giselle Sholler, MDStudy ChairBeat Childhood Cancer
16 Previous Clinical Trials
1,812 Total Patients Enrolled
14 Trials studying Neuroblastoma
1,303 Patients Enrolled for Neuroblastoma

Eligibility Criteria

Age < 65 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Is this a pioneering trial for its kind?

"Presently, 11 live clinical trials are taking place for Eflornithine across 699 cities and 12 countries. Cancer Prevention Pharmaceuticals, Inc. initiated the first trial in 2013 with 1340 participants which has since gone through its Phase 3 drug approval stage. In addition to this initial study, 10 other experiments have also been concluded so far." - Anonymous Online Contributor

Unverified Answer

What is the aggregate number of participants engaging in this research project?

"This clinical trial necessitates 131 participants who meet the inclusion standards. Patients can join in from sites such as Augusta University Health (Augusta, Georgia) and Children's Medical Center (Dallas, Texas)." - Anonymous Online Contributor

Unverified Answer

Are there still opportunities to join this research endeavor?

"Affirmative. The information posted on clinicaltrials.gov affirms that this medical trial is actively recruiting 131 patients at 23 sites, beginning September 25th 2020 and most recently updated April 20th 2022." - Anonymous Online Contributor

Unverified Answer

How widely dispersed is the experimental program?

"Augusta University Health in Augusta, Georgia, Children's Medical Center in Dallas, Texas, and the Medical University of South Carolina located in Charleston are some of the 23 research hubs associated with this medical trial." - Anonymous Online Contributor

Unverified Answer

What prior investigations have been conducted regarding Eflornithine?

"In 2013, the first studies of eflornithine were conducted at Lake Norman Hematology Oncology Specialists-Mooresville. To date, 10 trials have been concluded and there are 11 ongoing clinical tests - primarily located in Augusta, Georgia." - Anonymous Online Contributor

Unverified Answer

To what extent does Eflornithine pose a risk to individuals?

"Although there is some evidence of Eflornithine's safety, the lack of data concerning efficacy gives this medication a 2 on our team's safety scale." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top