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

Conditions

• Squamous Cell Carcinoma of the Oral Cavity
• Squamous Cell Carcinoma of the Soft Palate

Interventions

BIOLOGICAL

LI

LI 400 IU (2.0mL total daily) 1.0 mL peritumoral, 1.0 mL perilymphatic 5x weekly x3 consecutive weeks administered as neoadjuvant therapy prior to SOC, (surgery followed by radiation or concurrent radiochemotherapy with cisplatin 100 mg/m\^2 intravenously x3) to determine if LI plus CIZ affects the 3-5 year overall survival.

DRUG

Cyclophosphamide

Cyclophosphamide was administered IV bolus (one time only) at a dose of 300mg/m\^2 three days prior to beginning treatment with LI. Standard of care (SOC) for previously untreated squamous cell carcinoma of the head and neck is currently surgery followed by radiotherapy (60-70Gy in 30 to 35 fractions over 6 to 7 weeks) for higher risk subjects (subjects determined at surgery to have adverse features per the National Comprehensive Cancer Network (NCCN) guidelines, such as, positive surgical margins, 2 or more clinically positive nodes or extracapsular nodal spread, etc. that would pre-dispose them for higher risk of recurrence) radiotherapy is combined with concurrent chemotherapy (cisplatin 100mg/m\^2 intravenously on day 1 of weeks 1, 4 and 7 of radiotherapy.

DRUG

Indomethacin

One 25mg capsule of indomethacin was self administered orally (BID) beginning on day one of LI treatment daily until the day before surgery.

DIETARY_SUPPLEMENT

Zinc

One capsule daily self administered beginning on day one of treatment with LI until one day before surgery

PROCEDURE

Surgery

Excise tumor and nodes

DRUG

Cisplatin

Cisplatin was administered 100mg/m\^2 IV concurrent with radiotherapy. The chemotherapy agent (cisplatin 100mg/m\^2) was administered intravenously on day 1 of weeks 1, 4 and 7 of radiotherapy.

RADIATION

Radiotherapy

Total 60 to 70 Gy (2Gy per day) in 30 to 35 fractions over 6 to 7 weeks to subjects determined at surgery to be at lower risk for recurrence (per NCCN guidelines). For subjects determined at surgery to be at higher risk for recurrence due to having positive surgical margins, 2 or more clinically positive nodes or extracapsular nodal spread etc. (per NCCN guidelines), radiotherapy (as above) is combined with concurrent chemotherapy (cisplatin 100 mg/m\^2) intravenously on day 1 of weeks 1, 4 and 7 of radiotherapy.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.

  collaborator INDUSTRY

• Orient Europharma Co., Ltd.

  collaborator INDUSTRY

• CEL-SCI Corporation

  lead INDUSTRY

Principal Investigators

• Eyal Talor, PhD · CEL-SCI Corporation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2020-05-15

Completion

2020-12-04

Countries

• United States
• Austria
• Belarus
• Bosnia and Herzegovina
• Canada
• Croatia
• France
• Hungary
• India
• Israel
• Italy
• Malaysia
• Poland
• Romania
• Russia
• Serbia
• Spain
• Sri Lanka
• Taiwan
• Thailand
• Turkey (Türkiye)
• Ukraine
• United Kingdom

Study Locations