An Early Phase 1 interventional study of Fingolimod and Fingolimod Hydrochloride in Chemotherapy-Induced Peripheral Neuropathy, Numbness and Pain, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Mayo Clinic · Early Phase 1, Interventional, and Supportive care
This early phase I trial studies how well fingolimod works in treating patients with chemotherapy-induced nerve pain (neuropathy). Fingolimod acts by suppressing immune reactions in the brain. This study is being done to see if fingolimod can reduce neuropathy caused by chemotherapy.
PRIMARY OBJECTIVES:
I. To evaluate whether fingolimod markedly improves symptoms in patients with established (chemotherapy-induced peripheral neuropathy) CIPN.
II. To evaluate the tolerability of fingolimod in these treated patients.
OUTLINE:
Patients receive fingolimod orally (PO) once daily (QD) for 4 weeks.
After completion of study treatment, patients are followed up every month for 3 months.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's enrollment of 2 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pain or symptoms of CIPN of >= 3 months duration, for which the patient wants intervention.
Exclusion Criteria:
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
Uncontrolled intercurrent illness including, but not limited to:
Patients receive 0.5 mg dose of Fingolimod PO QD for 4 weeks. Take your Fingolimod approximately every 24 hours
Drug: Fingolimod · Drug: Fingolimod Hydrochloride · Other: Questionnaire Administration
Given PO daily for 4 weeks
Given PO
Also known as: FTY-720, FTY720, Gilenya
Ancillary studies
Serially measured total sensory neuropathy scores
Will be obtained from the 6 individual Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20) questions that quantify numbness, tingling, and pain in the fingers (or hands) and toes (or feet). The hypothesis will be tested with the two-sided one-sample t-test at a significance level of 10% reduction. In the event that the distribution of the within-patients change from baseline in total sensory neuropathy scores is not approximately normally distributed, then variable transformation or a nonparametric one-sample Wilcoxon signed-rank test will be considered as alternative approaches.
Time frame: Baseline up to 3 months post treatment
Incidence of adverse events (AEs) of fingolimod
The constellation of AEs as scored using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0) will be summarized by reporting the number and percentage of patients. Specifically, to evaluate the AE profiles, the maximum grade for each type of AE are recorded for each patient and data listings and frequency tables are clinically reviewed to determine overall patterns, including AE attribution (possible, probable, and definite) to fingolimod. Sensory neuropathy will be graded as none, mild, moderate, and severe. The percentage of patients experiencing an improvement in sensory neuropathy from baseline using NCI CTCAE v5.0 will be calculated with the exact 90% confidence interval.
Time frame: Up to 4 weeks
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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