Status:
COMPLETED
Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity
Lead Sponsor:
CEL-SCI Corporation
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D, Inc.
Orient Europharma Co., Ltd.
Conditions:
Squamous Cell Carcinoma of the Oral Cavity
Squamous Cell Carcinoma of the Soft Palate
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 (su...
Detailed Description
Head and neck carcinomas constitute about 5% of all cancers annually worldwide. In the US there are about 65,000 new cases annually. Ninety percent are squamous cell carcinoma of the head and neck (SC...
Eligibility Criteria
Inclusion
- Inclusion Criteria (main):
- Untreated SCCHN of oral cavity (anterior tongue, floor of mouth, cheek)/soft palate, categories T1N1-2M0,T2N1-2M0,T3N0-2M0,T4N0-2M0 (T4 allowed only if invasion of mandible is negligible i. e. 5mm or less) scheduled for SOC
- Primary tumor and any positive node(s) measurable in 2 dimensions
- Normal immune function
- No immunosuppressives with 1 year of entry
- KPS\>70/100
- Age\>18
- Male or Female (non-pregnant)
- Life expectancy \>6 months
- Able to take oral medication
- Able to provide informed consent
- Exclusion Criteria (main):
- Subjects to be treated with other than SOC
- Tumor invasion of bone (also see inclusion criteria)
- Tumor classifications T1N0, T2N0, T4N3, any TN classification with M1
- Tumors in locations other than those specified in inclusion criteria
- Active peptic ulcer (or on full-dose therapeutic anti-coagulants)
- Prior resection of jugular nodes ipsilateral to tumor
- Acute or chronic viral, bacterial immune or other disease associated with abnormal immune function
- Subjects on hemodialysis or peritoneal dialysis; or having a history of
- History of asthma, allergy to fluoroquinolone antibiotics, congestive heart failure, or on hemodialysis or peritoneal dialysis
- Any condition that in the opinion of the investigator would cause the subject to be unable to participate or tolerate the protocol regimen
- Failure to meet inclusion criteria
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2020
Estimated Enrollment :
928 Patients enrolled
Trial Details
Trial ID
NCT01265849
Start Date
December 1 2010
End Date
December 4 2020
Last Update
August 19 2022
Active Locations (102)
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1
Simmons Cancer Institute at Southern Illinois University
Springfield, Illinois, United States, 62794
2
Henry Ford Health System Henry Ford Hospital
Detroit, Michigan, United States, 48202
3
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
4
Medical College Of South Carolina MSC550
Charleston, South Carolina, United States, 29435