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Anti-cancer drug
DFMO + Etoposide for Neuroblastoma
Phase 2
Recruiting
Research Sponsored by Giselle SaulnierSholler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
i. No evidence of residual disease by CT/MRI and MIBG scan (or PET for patients who have a history of MIBG non-avid disease).
ii. No evidence of disease metastatic to bone marrow.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years plus 5 years follow up
Awards & highlights
Study Summary
This trial will test the combination of DFMO and etoposide for subjects with relapsed/refractory neuroblastoma.
Who is the study for?
This trial is for individuals under 31 years old with neuroblastoma that has come back or didn't respond to treatment. They must have completed at least 4 cycles of intense chemotherapy, have good organ function, and a performance score of 60% or higher. Women who can have children need a negative pregnancy test and agree to use birth control.Check my eligibility
What is being tested?
The study tests Eflornithine (DFMO) in combination with etoposide on patients with relapsed/refractory neuroblastoma. It's an open-label, multicenter trial meaning all participants know what treatment they're getting and it involves multiple locations.See study design
What are the potential side effects?
Possible side effects include suppression of bone marrow leading to low blood counts, digestive issues from etoposide such as nausea or vomiting, potential liver problems indicated by changes in certain blood tests, fatigue, hair loss, and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My scans show no remaining cancer.
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My cancer has not spread to my bone marrow.
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I have completed at least 4 cycles of intense chemotherapy.
Select...
I do not have active symptoms from a transplant rejection.
Select...
It has been over 8 weeks since my last MIBG therapy.
Select...
It has been over 2 months since my transplant.
Select...
I can do most activities but may need help.
Select...
My cancer can be seen on scans or confirmed through a biopsy.
Select...
I am 30 years old or younger with a confirmed neuroblastoma diagnosis that has come back or didn't respond to treatment.
Select...
My liver functions are within the required range.
Select...
My kidney function is good based on tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years plus 5 years follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years plus 5 years follow up
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
Determine the Overall Response Rate (ORR) of Participants using INSS Response Evaluation Criteria.
Length of time that participants experience Overall Survival (OS)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Side effects data
From 2019 Phase 3 trial • 171 Patients • NCT0148314421%
nausea
14%
abdominal pain
14%
upper respiratory tract infection
14%
headache
13%
gastroenteritis
13%
abdominal pain upper
13%
diarrhoea
13%
rectal haemorrhage
11%
haematochezia
11%
nasopharyngitis
11%
rash
11%
vomiting
9%
back pain
9%
influenza like illness
9%
flatulence
9%
oropharyngeal pain
7%
dizziness
7%
arthralgia
7%
myalgia
7%
fatigue
7%
influenza
7%
sinusitis
5%
neck pain
5%
pouchitis
5%
cough
5%
gastritis erosive
5%
gastroenteritis viral
5%
small bowel obstruction
5%
pruritus
5%
constipation
5%
dry skin
5%
urticaria
4%
weight increased
4%
small intestinal obstruction
4%
decreased appetite
4%
abdominal distension
4%
dyspepsia
4%
anxiety
4%
alopecia
4%
urinary tract infection
2%
bursitis
2%
pulmonary mass
2%
contusion
2%
wound dehiscence
2%
seroma
2%
ileus
2%
pancreatitis acute
2%
inguinal hernia
2%
seasonal allergy
2%
nasal congestion
2%
insomnia
2%
hyperglycaemia
2%
bronchitis
2%
nephritis
2%
renal failure acute
2%
depression
2%
lung adenocarcinoma
2%
ear pain
2%
psychotic disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Eflornithine Plus Sulindac
Eflornithine Plus Sulindac Placebo
Sulindac Plus Eflornithine Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Eflornithine (DFMO)Experimental Treatment1 Intervention
In this study subjects will receive six 21-day cycles of Etoposide and DFMO followed by an additional 630 days of DFMO alone.
Etoposide will be given at 50 mg/m2/dose PO daily for the first 14 days of each 21 days until 6 cycles of etoposide are completed.
DFMO (difluoromethylornithine) will be given at a dose of 1000 mg/m2 BID on each day of study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eflornithine
1998
Completed Phase 3
~830
Find a Location
Who is running the clinical trial?
Giselle SaulnierShollerLead Sponsor
21 Previous Clinical Trials
2,091 Total Patients Enrolled
18 Trials studying Neuroblastoma
1,464 Patients Enrolled for Neuroblastoma
Wake Forest University Health SciencesLead Sponsor
1,247 Previous Clinical Trials
1,004,971 Total Patients Enrolled
19 Trials studying Neuroblastoma
1,521 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never taken DFMO at a dose higher than 1000mg/m2 twice a day before this study.My scans show no remaining cancer.I will start the trial within 60 days of my last cancer treatment.I have recovered from previous cancer treatments without lingering side effects.It has been over 6 weeks since I last received any form of immunotherapy.My body surface area is less than 0.25 square meters.I am not currently on any cancer treatments and have recovered from previous ones.My scans may show masses, but tests confirm no active cancer.I finished my biologic cancer treatment at least 7 days ago.My cancer has not spread to my bone marrow.I have completed at least 4 cycles of intense chemotherapy.I do not have active symptoms from a transplant rejection.It has been over 14 days since my last radiation treatment, except for palliative care.I am eligible for either the first or second part of the study.It has been over 8 weeks since my last MIBG therapy.It has been over 2 months since my transplant.It's been over 2 weeks since my last monoclonal antibody treatment.I can do most activities but may need help.It has been over 5 days since my last growth factor therapy.My organs are functioning well.My cancer can be seen on scans or confirmed through a biopsy.I have never taken DFMO with etoposide.I am 30 years old or younger with a confirmed neuroblastoma diagnosis that has come back or didn't respond to treatment.My liver functions are within the required range.I have given my written consent to participate.My kidney function is good based on tests.I haven't had chemotherapy that lowers blood cell counts in the last 2 weeks (or 6 weeks for a specific type).I have undergone a stem cell transplant.My condition is currently stable with no active disease.
Research Study Groups:
This trial has the following groups:- Group 1: Eflornithine (DFMO)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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)."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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