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

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

Outcome

Mixed primary results

registry analysis (superiority test); LI + CIZ + SOC vs Standard of Care (SOC); p = 0.4051; Log Rank NCT01265849 ↗

registry MEDIAN LI + CIZ + SOC: 101.7 (64.1 to 101.7) months NCT01265849 ↗

registry analysis (superiority test); LI + CIZ + SOC vs Standard of Care (SOC); p = 0.0478; Log Rank NCT01265849 ↗

paper ITT low-risk LI + CIZ + SOC demonstrated significant OS advantage vs. ITT low-risk SOC PMID 40191245 ↗

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

Indications