NCT01265849|CompletedPhase 3ResultsDMC

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

IT-MATTERS

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

CEL-SCI Corporation ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CS001P3

Secondary identifiers

2010-019952-35

EUDRACT_NUMBER

Study Type

interventional

Actual enrollment (reported)

928

Locations

23 countries

Sites

102

Timeline

Study Start

December 2010

Actual (reported)

Primary Completion

May 15, 2020

Actual (reported)

Study Completion

December 4, 2020

Actual (reported)

Brief 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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 928 participants
Study completion date: December 4, 2020
Actual (reported)
Listed locations: 23 countries · 102 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2010
Actual (reported)
First Submitted
December 22, 2010
Actual (reported)
First Posted
December 23, 2010
Actual (reported)
Primary Completion
May 15, 2020
Actual (reported)
Study Completion
December 4, 2020
Actual (reported)
Results Posted
August 19, 2022
Actual (reported)

Last Updated: August 19, 2022
Status Verified: August 2022
Results QC Date: August 17, 2022
Last Update Submitted: August 17, 2022

Conditions

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

Outcome Measures

Primary Outcomes (2)

Interventions

LIBiological

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.

Also known as: Multikine, Leukocyte interleukin, injection

LI + CIZ + SOCLI + SOC

CyclophosphamideDrug

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.

LI + CIZ + SOC

IndomethacinDrug

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

LI + CIZ + SOC

ZincDietary supplement

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

Also known as: Multivitamins

LI + CIZ + SOC

SurgeryProcedure

Excise tumor and nodes

LI + CIZ + SOCLI + SOCStandard of Care (SOC) only

CisplatinDrug

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.

LI + CIZ + SOCLI + SOCStandard of Care (SOC) only

RadiotherapyRadiation

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.

LI + CIZ + SOCLI + SOCStandard of Care (SOC) only

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (102)

Simmons Cancer Institute at Southern Illinois University

Springfield, Illinois, 62794, United States

Henry Ford Health System Henry Ford Hospital

Detroit, Michigan, 48202, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Medical College Of South Carolina MSC550

Charleston, South Carolina, 29435, United States

VA Puget Sound Healthcare System & University of WA

Seattle, Washington, 98108, United States

HNO-Klinik der medizinischen Universitat Graz

Graz, 8036, Austria

N.N. Alexandrov Research Istitute of Oncology and Medical Radiology

Lyasny, Minsk Oblast, 223040, Belarus

Vitebsk Regional Oncology Dispensary

Vitebsk, 210603, Belarus

University Clinical Centre Tuzla

Trnovac, Tuzla, 75 000, Bosnia and Herzegovina

Clinical Center Banja Luka

Banja Luka, 78 000, Bosnia and Herzegovina

University Clinical Hospital Mostar

Mostar, 88000, Bosnia and Herzegovina

Clinical Centre University of Sarejevo Clinic for ENT

Sarajevo, 71000, Bosnia and Herzegovina

St. Josephs Healthcare Department of Surgery

Hamilton, Ontario, L8N4A6, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, JiH 5N4, Canada

CHU de Quebec - L'Hotel Dieu de Quebec

Québec, G1R2J6, Canada

CHC Osijek

Osijek, 31000, Croatia

General Hospital Dr. Josip Bencevic

Slavonski Brod, 35000, Croatia

CH Dubrava

Zagreb, 10000, Croatia

Clinical Hospital Center Zagreb Kispaticeva 12

Zagreb, 10000, Croatia

KBC Sestre Milosrdnice

Zagreb, 10000, Croatia

KBC Zagreb

Zagreb, 10000, Croatia

ICL 6 avenue Bourgogne CS30519

Vandœuvre-lès-Nancy, 54519, France

University of Debrecen Medical and Health Scioence Centre

Debrecen, Hajdú-Bihar, krt. 98, Hungary

National institute of Oncology

Budapest, Rath Gyorgy, H-1122, Hungary

Semmelweis University

Budapest, 1085, Hungary

University of Pecs Institute of Oncotherapy

Pécs, 7628, Hungary

University of Szeged Dept of Oral and Maxillofacial Surgery

Szeged, 6725, Hungary

Markusovsky Teaching Hospital

Szombathely, 9700, Hungary

Bibi General Hospital and Cancer Centre

Malkapet, Andhra Pradesh, 500024, India

Amrita Institute of Medical Sciences

Kochi, Kerala, 682041, India

Sujan Regional Cancer Hospital & Amravati Cancer Foundation

Amravati, Maharashtra, 444606, India

Government Medical College and Hospital

Aurangabad, Maharashtra, 431001, India

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Curie Manavata Cancer Center

Mumbai, Naka Nashik, 422004, India

Searoc Cancer Center

Jaipur, Rajashlan, 302013, India

V.N. Cancer Center G. Kuppuswamy Naidu Memorial Hospital

Coimbatore, Tamil Nadu, 641037, India

Meenakshi Mission Hospital and Research Centre

Madurai, Tamil Nadu, 625107, India

Regional Cancer Center

Kerola, Thiruvananthapuram, 695011, India

Galaxy Cancer Center

Ghaziabad, Uttar Pradesh, 210010, India

Rambam Health Care Campus

Sha‘ar Ha‘Aliya, Saint Haifa, 31906, Israel

Rabin Medical Center

Petah Tikva, Tikva, 49100, Israel

National Tumor Institute of Italy

Naples, 80131, Italy

Ospedale S.G. Moscati Santissima Annunziata

Taranto, 74010, Italy

Dept of Head and Neck Surgery School of Medical Sciences Univ. Sains

Kuantan, Pulau Pinang, 16150, Malaysia

University Kabangsan Medical Center

Kuala Lumpur, 56000, Malaysia

Wojewodzki Szpital Specjalistyczny im Kopernika

Lodz, Ul Paderewskiego 4, 93-509, Poland

Swietokrzyskie Centrum Onkologii

Kielce, Ul. Artwinskiego 3, 25-734, Poland

Centrum Onkologi-Instytut im. Marie Sklodowskiej-Curie

Warsaw, Ul. Roentgena 5, 02-781, Poland

Centrum Onkologii im. Prof. Lukaszcyka

Warsaw, Ul. Roentgena 5, 02-781, Poland

ul. M. Sklodowskiej-Curie 24A

Bialystok, 15-276, Poland

Szpital Specialistyczny im. Ludwika Rydgiera

Krakow, 31826, Poland

Samodzielny Publiczny Szpital Kliniczny Klinika Otolarryngologii I Onkologii Laryngologicznej

Lublin, 20-954, Poland

Weilkopolskie Centrum Onkologii Klinika Chirurgii Glowy Szye Onkologii Laryngologiczne

Poznan, 61-866, Poland

Uniwersitecki Szpital Kliniczny Klinika Otolaryngologii Chirugii Glowy i Szxyi

Wroclaw, 50-556, Poland

Regional Institute of Oncology IASI

Iași, 700483, Romania

Spital Clinic Judetean Mures

Târgu Mureş, 540072, Romania

Sverdlovsk Regional Cancer Center

Sverdlov, Ekaterinberg, 620905, Russia

Leningrad Regional Oncology Center

Saint Petersburg, Leningradskaya, 188663, Russia

Kursk Regional Clinical Oncology Dispensary

Kursk, 305035, Russia

Blokhin Cancer Research Center

Moscow, 115478, Russia

N.N. Blokhin Russian Cancer Research Center

Moscow, 115478, Russia

Budget Institution of Healthcare of Omsk Region Clincal Oncology Dispensary

Omsk, 644013, Russia

Ryazan Clinical oncology Dispensary

Ryazan, 39011, Russia

Serbia Clinic for ENT and Maxillofacial Surgery

Belgrade, Pasterova 14, 11000, Serbia

Clincal Center Serbia Clinic for Oral and Maxillofacial Surgery

Belgrade, 11000, Serbia

Faculty of Dental Medicine Clinic for Maxillofacial Surgery

Belgrade, 11000, Serbia

Military Medical Academy Clinic for Maxillofacial Surgery

Belgrade, 11000, Serbia

Clinical Center Nis center for Oncology

Niš, 18 000, Serbia

Clinic for Stomatology department for maxillofacial Surgery

Niš, 18000, Serbia

Clinical center Vojvodina Clinic for ORL

Novi Sad, 21000, Serbia

Clinical Centre Vojvodina Clinic for Maxillofacial Surgery

Novi Sad, 21000, Serbia

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Hospital Universitario de Princesa

Madrid, 28006, Spain

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Hospital Madrid North Universitaro de Sanchinnaro

Madrid, 28050, Spain

Complejo Hospitalario Univ. de Santiago

Santiago de Compostela, 15706, Spain

Consorsio Hospital General Universitario de valencia

Valencia, 46014, Spain

National Cancer Institute Dept of Clinical Oncology & Radiotherapy

Colombo, 10280, Sri Lanka

Oncology Unit Teaching Hospital Karapitya

Galle, Sri Lanka

Kaohsiung Branch Chang Gung Memorial Hospital

Niaosong, Kaohsiung, 833, Taiwan

National Cheng Kung University Hospital

Taipei, Tainan, 704, Taiwan

National Taiwan Research Hospital

Chengshan, Taipei, 100, Taiwan

Linkou Branch Chang Gung Memorial Hospital

Guishan, Taoyuan, 333, Taiwan

Changua Christian Hospital

Chang-hua, 500, Taiwan

Buddhist Tzu Chi General Hospital, Hualien Branch

Hualien City, 970, Taiwan

China Medical University Hospital

Taichung, 404, Taiwan

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Shin-Kong Wu Ho-Su Memorial Hospital

Taipei, 111, Taiwan

Khon Kaen University Dept of Otolaryngology

Nai Muang, 40002, Thailand

Haceteppe University Dept of Otolaryngology - Head and Neck Surgery

Ankara, 06100, Turkey (Türkiye)

Acibadem University Maslak Hospital ENT Department

Istanbul, Turkey (Türkiye)

Cherkasky Regional Oncological Dyspensary Dept. Head and Neck tumour

Cherkasy, 18009, Ukraine

Clinical Diagnostic Laboratory of Dnepropetrovsk Municipal Institution City Multidisciplinary Clinical Hospital No. 4

Dnipro, 49102, Ukraine

Donetsk Regional Antitumor Center

Donetsk, 83092, Ukraine

Grigoriev Institute for Medical Radiology of National Academy of Medical Science of Ukraine Dept. of Remote, Combined Radiation and Complex Therapy

Kharkiv, 61024, Ukraine

Kharkiv Regional Clinical Oncology Center Dept. Of Head and Neck Tumour

Kharkiv, Ukraine

Kiev City Clinical Oncology Center of the Main Health Care Dept of Kiev Day Hospital Radiotherapy Dept.

Kiev, Ukraine

Kiev City Clinical Oncology Center of the Main Health Care Dept. of the Kiev Day Hospital

Kiev, Ukraine

Lviv State OncologyRegional treatment and Diagnostic Center

Lviv, 79031, Ukraine

Sumy Regional Clinical Oncology Dyspensary

Sumy, 40004, Ukraine

Zaporiz'ka Regional Clinical Oncology Dispensary

Zaporiz'ka Oblast', 69040, Ukraine

Aintree University Hospital

Liverpool, L9 7AL, United Kingdom

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Study Arms (3)

LI + CIZ + SOC

Standard of Care (SOC) only

LI + SOC

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (102)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

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Study Record Dates

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Source record

Documents

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