SNPMiner Trials (Home Page)
Report for SNP rs2302616
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 A Phase II Preventative Trial of DFMO (Eflornithine HCl) as a Single Agent in Patients With High Risk Neuroblastoma in Remission
The purpose of this research study is to evaluate a new investigational drug to prevent reoccurrence of neuroblastoma that is in remission. This study drug is called DFMO. The objectives of this study will be to monitor for safety and look at efficacy of DFMO. The safety of the proposed dosing regimen in this trial will be tested by an on-going risk/benefit assessment during the study. A patient benefiting from treatment, not progressing on therapy, and in the absence of any safety issues associated with DFMO may continue on treatment up to 27 cycles with the expectation that there will be an overall clinical benefit. The procedures involved in this study include Medical history, Physical exam, Vital signs (blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the tumor(s), meta-iodobenzylguanidine (MIBG) scans, and Bone marrow aspirations. All of these tests and procedures are considered standard of care for this population. Drug administration is also part of this protocol, including an investigational new drug called DFMO. The proposed dosing regimen is an oral dose of DFMO tablets two times a day for each day while on study. There will be 27 cycles. Each cycle will be 28 days in length.
NCT02395666 Neuroblastoma Drug: DFMO MeSH:Neuroblastoma
HPO:Neuroblastoma
Tests (p-value) of the association of survival with ODC1 single nucleotide polymorphism rs2302616 genotype.
Primary Outcomes
Description: To evaluate the preventative activity of DFMO as a single agent in patients that are in remission based on: Event free survival (EFS)
Measure: Number of Participants With Event Free Survival (EFS) During Study. Time: 2 YearsSecondary Outcomes
Description: To evaluate the preventative activity of DFMO as a single agent in patients with neuroblastoma who are in remission based on: Overall Survival (OS)
Measure: Percentage of Participants With Overall Survival (OS) Time: 2 YearsDescription: To continue to determine the safety and tolerability of DFMO as a single agent and in pediatric and young adult patients with high risk neuroblastoma that is in remission.
Measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability Time: 2 yearsDescription: Tests (p-value) of the association of survival with ODC1 single nucleotide polymorphism rs2302616 genotype. Blood: microRNA analysis as predictor of DFMO effect, ornithine decarboxylase (ODC) single nucleotide polymorphism (SNP) analysis in DNA isolated from nucleated cells
Measure: Test the Association of Survival With ODC1 Genotype Time: 2 yearsDescription: circulating tumor cell analysis
Measure: Circulating Tumor Cell Analysis Time: 5 yearsDescription: Pharmacokinetic assay Cmax/D Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days.
Measure: Peak Plasma Concentration (Cmax) Time: Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different daysDescription: Pharmacokinetic assay AUC(0-6 hr)/D Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days
Measure: Area Under the Plasma Concentration Versus Time Curve (AUC) Time: 0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose on two different daysDescription: Pharmacokinetic assay- tmax, hr Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days
Measure: Time to Reach Peak Plasma Concentration (Tmax) Time: 0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose on two different days