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

A Phase III, Open-label, Randomized, Multi-center Study of the Effects of Leukocyte Interleukin, Injection [Multikine] Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity / Soft Palate Versus Standard of Care Only

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2014/017

Enrollment

Unknown

Registered

2014-08-25

Start date

2014-08-25

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma of the Oral Cavity and soft palate

Interventions

Interventions will be as follows 1. Leukocyte Interleukin (Multikine): 400IU Multikine (2.0mL total daily) 1.0 mL peritumoral, 1.0 mL perilymphatic will be administered 5 times a week for 3 weeks 2.

Eligibility

Inclusion criteria

Inclusion criteria: Ages Eligible for Study : 18 Years and older Genders Eligible for Study : Both Accepts Healthy Volunteers: No 1. Untreated SCCHN of oral cavity/soft palate, categories T1N1-2M0,T2N1-2M0,T3N0-2M0,T4N0-2M0 (T4 allowed only if invasion of mandible is negligible) scheduled for SOC 2. Primary tumor and any positive node(s)measurable in 2 dimensions 3. Normal immune function 4. No immunosuppressives with 1 year 5. Karnofsky Performance Status (KPS) >70 6. Age>18 7. Male or Female (non-pregnant) 8. Life expectancy >6 months 9. Able to take oral medication 10. Able to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Subjects to be treated with other than SOC 2. Tumor invasion of bone (also see inclusion criteria) 3. Tumor classifications T1N0, T2N0, T4N3, any TN classification with M1 4. Tumors in locations other than those specified in inclusion criteria 5. Active peptic ulcer 6. Prior resection of jugular nodes ipsilateral to tumor 7. Acute or chronic viral, bacterial immune or other disease associated with abnormal immune function 8. Subjects on hemodialysis or peritoneal dialysis 9. History of asthma 10. Any condition that in the opinion of the investigator would cause the subject to be unable to participate or tolerate the protocol regimen

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS) in LI + CIZ + SOC vs. SOC OS will be assessed using Kaplan-Meier life-table [From randomization up to 3 years ]	—

Secondary

Measure	Time frame
1. Progression Free Survival (PFS) in LI + CIZ + SOC vs.SOC [PFS will be assessed using Kaplan-Meier life-table and compared using a logrank test ] 2. Local regional control (LRC) in LI + CIZ + SOC vs. SOC [LRC will be assessed by classifying the first evidence of progression in local and distal sites for the control group and for the LI treated group]. 3. Quality of Life (QOL) in LI + CIZ + SOC vs. SOC [QOL will be based on the EORTC QLOQ-C30 and EORTC QLQ-H&N35]. [From randomization up to 3 years]	—

Measure

Time frame

1. Progression Free Survival (PFS) in LI + CIZ + SOC vs.SOC [PFS will be assessed using Kaplan-Meier life-table and compared using a logrank test ] 2. Local regional control (LRC) in LI + CIZ + SOC vs. SOC [LRC will be assessed by classifying the first evidence of progression in local and distal sites for the control group and for the LI treated group]. 3. Quality of Life (QOL) in LI + CIZ + SOC vs. SOC [QOL will be based on the EORTC QLOQ-C30 and EORTC QLQ-H&N35]. [From randomization up to 3 years]

—

Countries

Canada,Croatia,Hungary,India,Israel,Poland,Russian Federation,Serbia,Sri Lanka,Taiwan, Province of China,Ukraine,United States

Contacts

Public ContactDr Prasad Abeysinghe/ Principal Investigator

Consultant Clinical Oncologist

prasadabeysinghe@hotmail.com+94112850253, +94115219290

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026