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Proteasome Inhibitor
DFMO + Bortezomib for Neuroblastoma
Phase 1 & 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 3 years
Awards & highlights
Study Summary
This trial is testing an investigational drug (DFMO) in combination with bortezomib for relapsed and refractory neuroblastoma. It will evaluate safety, tolerability, and tumor response.
Who is the study for?
This trial is for young people (≤21 years at diagnosis) with neuroblastoma that's come back or didn't respond to treatment. They should have tried a strong chemo combo including an alkylating agent and platinum, and there shouldn't be any known cure or life-extending therapy left for them. Girls who can have babies must test negative for pregnancy.Check my eligibility
What is being tested?
The study tests DFMO, not yet approved by the FDA, combined with bortezomib in patients whose neuroblastoma has relapsed or is resistant to treatment. It aims to see how safe this mix is and how well tumors respond.See study design
What are the potential side effects?
While specific side effects are not listed here, investigational drugs like DFMO could cause unexpected reactions, and bortezomib may lead to nerve damage, digestive issues, blood cell count changes, fatigue, and increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the Overall Response Rate (ORR) of Participants using RECIST criteria
Secondary outcome measures
Determine the Progression Free Survival (PFS) of Participants using days until progression
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Side effects data
From 2023 Phase 2 trial • 140 Patients • NCT0239566610%
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 and BortezomibExperimental Treatment2 Interventions
Subjects will take DFMO by mouth 2 times a day for each day of a 21 day cycle and Bortezomib will be given by IV push on days 1, 4, and 8 of each 21 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib
2005
Completed Phase 2
~1140
DFMO
2010
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
Because of EzraOTHER
1 Previous Clinical Trials
140 Total Patients Enrolled
1 Trials studying Neuroblastoma
140 Patients Enrolled for Neuroblastoma
K C Pharmaceuticals Inc.Industry Sponsor
4 Previous Clinical Trials
771 Total Patients Enrolled
4 Trials studying Neuroblastoma
771 Patients Enrolled for Neuroblastoma
Giselle ShollerLead Sponsor
21 Previous Clinical Trials
2,189 Total Patients Enrolled
18 Trials studying Neuroblastoma
1,562 Patients Enrolled for Neuroblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your ability to perform daily activities is severely limited, with a score of less than 50% on the Lansky scale.
Research Study Groups:
This trial has the following groups:- Group 1: DFMO and Bortezomib
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.
Could you compare and contrast this DFMO study to others like it?
"DFMO's first clinical trial was completed in 2004 at the National Institutes of Health Clinical Center. As of now, 395 have been completed with 156 more underway. A significant amount of these ongoing trials are based out of Little Rock, Arkansas."
Answered by AI
Are we looking for more participants in this experiment?
"The clinical trial in question is not recruiting new participants, as per the information on clinicaltrials.gov. This study was first posted on May 1st, 2014 and was last updated on April 20th, 2022. 321 other trials are currently enrolling patients."
Answered by AI
What are the benefits of using DFMO?
"DFMO has been successful in treating hair removal therapy, meningoencephalitic stage trypanosoma brucei gambiense infection, and multiple myeloma."
Answered by AI
How many different sites are conducting this research?
"There are a total of six different hospitals participating in this study. These include the Arkansas Children's Hospital in Little Rock, Medical University of South carolina in Charleston, and Arnold Palmer Hospital for Children- MD Anderson in Orlando."
Answered by AI
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