IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity

PHASE2CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

January 11, 2016

Primary Completion Date

February 28, 2022

Study Completion Date

February 28, 2022

Conditions
Squamous Cell Carcinoma of the Oral Cavity
Interventions
BIOLOGICAL

IRX-2

Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck.

DRUG

Cyclophosphamide

Method of Administration: Cyclophosphamide is administered once by IV

DRUG

Indomethacin

Method of Administration: Indomethacin is administered orally for 21 days.

DIETARY_SUPPLEMENT

Zinc-containing multivitamin

Method of Administration: Zinc-containing multivitamin is administered orally for 21 days.

DRUG

Omeprazole

Method of Administration: Omeprazole is administered orally for 21 days

Trial Locations (22)

10075

Lenox Hill Hospital, New York

11040

Monter Cancer Center - North Shore LIJ, New Hyde Park

19106

Hospital of The University of Pennsylvania, Philadelphia

30322

Emory University - Winship Cancer Center, Atlanta

40506

University of Kentucky, Lexington

48109

University of Michigan, Ann Arbor

68114

Nebraska Methodist Hospital, Omaha

72205

University of Arkansas For Medical Sciences, Little Rock

73104

University of Oklahoma, Oklahoma City

85742

Banner University Medical Center, Tucson

90033

USC Norris Comprehensive Cancer Center, Los Angeles

94305

Stanford University Medical Center, Stanford

97209

Providence Cancer Center, Portland

Unknown

Hospital Erasto Gaertner, Curitiba

Instituto Goiano de Oncologia e Hematologia (INGOH), Goiânia

Instituto do Câncer de Londrina, Londrina

Instituto Nacional do Cancer (INCA), Rio de Janeiro

Hospital de Base de São José do Rio Preto, São José do Vale do Rio Preto

Instituto Brasileiro de Controle do Câncer, São Paulo

Instituto do Cancer do Estado de São Paulo - ICESP, São Paulo

Sunnybrook Research Institute, Toronto

Queen Elizabeth University Hospital Glasgow, Glasgow

All Listed Sponsors
lead

Brooklyn ImmunoTherapeutics, LLC

INDUSTRY

NCT02609386 - IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity | Biotech Hunter | Biotech Hunter