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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01265849

Public ClinicalTrials.gov record NCT01265849. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 12:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase III Study of LI [Multikine®] Plus SOC (Surgery + Radiotherapy or Surgery + Concurrent Radiochemotherapy) in Subjects With Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate vs. SOC Only

Study identification

NCT ID
NCT01265849
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
CEL-SCI Corporation
Industry
Enrollment
928 participants

Conditions and interventions

Interventions

  • LI Biological
  • Cyclophosphamide Drug
  • Indomethacin Drug
  • Zinc Dietary Supplement
  • Surgery Procedure
  • Cisplatin Drug
  • Radiotherapy Radiation

Biological · Drug · Dietary Supplement + 2 more

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2010
Primary completion
May 14, 2020
Completion
Dec 3, 2020
Last update posted
Aug 18, 2022

2010 – 2020

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
Simmons Cancer Institute at Southern Illinois University Springfield Illinois 62794
Henry Ford Health System Henry Ford Hospital Detroit Michigan 48202
University of Cincinnati Medical Center Cincinnati Ohio 45219
Medical College Of South Carolina MSC550 Charleston South Carolina 29435
VA Puget Sound Healthcare System & University of WA Seattle Washington 98108

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 97 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01265849, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 18, 2022 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01265849 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →