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DFMO + Etoposide for Neuroblastoma
Study Summary
This trial will test the combination of DFMO and etoposide for subjects with relapsed/refractory neuroblastoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 171 Patients • NCT01483144Trial Design
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- 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.It's been over a week since my last biologic 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 scans show no active cancer, even if there are leftover masses.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.I haven't had chemotherapy that lowers blood cell counts in the last 2 weeks (or 6 weeks for a specific type).I have recovered from previous cancer treatments without lingering side effects.My scans may show masses, but tests confirm no active cancer.My liver functions are within the required limits.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.I am 30 years old or younger with a confirmed diagnosis of neuroblastoma that has come back or did not respond to treatment.My condition is currently stable with no active disease.My scans show no signs of cancer remaining.It's been over 2 weeks since my last monoclonal antibody treatment.It's been over 2 weeks since my last radiation therapy, except for palliative care.My condition is currently stable with no active disease.I have completed at least 4 cycles of intense chemotherapy.My cancer has not spread to my bone marrow.My cancer can be seen on scans or confirmed through a biopsy.It has been over 2 months since my transplant.I have undergone a stem cell transplant.It's been over 5 days since I last received treatment with growth factors.I do not have active symptoms from a transplant rejection.My kidney function is good based on tests.I can do most activities but may need help.It has been over 8 weeks since my last MIBG therapy.My organs are functioning well.It has been over 6 weeks since I last received any form of immunotherapy.You are expected to live for at least 2 more months.I am eligible for either the first or second part of the study.I have given my written consent to participate.
- Group 1: Eflornithine (DFMO)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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)."
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."
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."
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."
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."
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