NCT03943498

Fingolimod in Treating Patients With Chemotherapy-Induced Neuropathy

Treatment of Established Chemotherapy-Induced Neuropathy With Fingolimod: A Pilot Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chemotherapy-Induced Peripheral Neuropathy
• Numbness
• Pain
• Tingling

Interventions

Type	Name	Description
DRUG	Fingolimod	Given PO daily for 4 weeks
DRUG	Fingolimod Hydrochloride	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2019-05-24
• Primary completion: 2020-12-10
• Completion: 2020-12-10
• First posted: 2019-05-09
• Last updated: 2023-09-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study