Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity

Phase 3 Completed 928 enrolled CEL-SCI Corporation Orient Europharma Co., Ltd. · collab Teva Branded Pharmaceutical Products R&D, Inc. · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to determine whether LI administered in combination with cyclophosphamide, indomethacin and zinc in a multivitamin (CIZ) combination prior to standard of care therapy (surgery followed by radiotherapy or concurrent radiochemotherapy) is safe and will increase the overall survival of subjects with previously untreated locally advanced primary squamous cell carcinoma of the oral cavity or soft palate at a median of 3 to 5 years

Timeline

Start: 2010-12
Primary completion: 2020-05-15
Completion: 2020-12-04

Publications

Talor E, Timar J, Lavin P, Cipriano J, Markovic D, Ladanyi A, Karpenko A, Bondarenko I, Stosic S, Sobat H, Zhukavets A, Imamovic N, Chien CY, Bankowska-Wozniak M, Kisely M, Jovic R, Young JEM, Hao SP. Neoadjuvant leukocyte interleukin injection immunotherapy improves overall survival in low-risk locally advanced head and neck squamous cell carcinoma -the IT-MATTERS study. Pathol Oncol Res. 2025 Mar 21;31:1612084. doi: 10.3389/pore.2025.1612084. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclophosphamide	Other / unclassified	300 mg/m2	Intravenous
Subject	Indomethacin	Small molecule	25 mg	Oral
Subject	LI	Unknown	400 iu	Other
Background	Cisplatin	Other / unclassified	100 mg/m2	Intravenous

Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity

Summary

Timeline

Publications

Drugs

Indications