Phase 3 N=928 Randomized Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT01265849 ↗

Enrolled (actual)

928

Serious AEs

53.8%

Results posted

Aug 2022

Primary outcome: Primary: Overall Survival (OS) — 46.3; 58.1; 52.9 months — p=0.4051

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: LI (Biological); Cyclophosphamide (Drug); Indomethacin (Drug); Zinc (Dietary_supplement); Surgery (Procedure); Cisplatin (Drug); Radiotherapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: CEL-SCI Corporation
Primary completion: May 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival (OS)	46.3; 58.1; 52.9	0.4051
PRIMARY OS in Low Risk Subjects	101.7; 68.2; 55.2	0.0478 sig
SECONDARY Local Regional Control (LRC)	NA; NA; NA	0.7304
SECONDARY LRC in Low Risk Subjects	NA; NA; NA	0.6142
SECONDARY Progression Free Survival (PFS)	32.4; 37.0; 45.5	0.3303
SECONDARY PFS in Low Risk Subjects	66.4; 68.2; 51.5	0.1797
SECONDARY Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 2	0.28; 7.95; 3.29	0.2100
SECONDARY Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 36	7.64; 10.79; 6.33	0.5871
SECONDARY EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 2	-2.75; -2.80; -3.81; 8.11; 6.29; 7.31	0.6296
SECONDARY EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 36	-9.47; -8.63; -8.42; 6.90; 1.66; 8.94	0.6337
SECONDARY Statistical Comparisons of Time-to-event Outcomes (OS, LRC, PFS) Were Repeated for Varying Levels of Histopathology (HP) Markers in Low Risk Subjects	61; 0	<0.05 sig

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01265849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.