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

Phase 3

Conditions: Squamous Cell Carcinoma of the Oral Cavity and soft palate

Registration Number: SLCTR/2014/017

Lead Sponsor: Dr. E Talor

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete: follow up complete

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

1. Untreated SCCHN of oral cavity/soft palate, categories T1N1-2M0,T2N1-2M0,T3N0-2M0,T4N0-2M0 (T4 allowed only if invasion of mandible is negligible) scheduled for SOC
2. Primary tumor and any positive node(s)measurable in 2 dimensions
3. Normal immune function
4. No immunosuppressives with 1 year
5. Karnofsky Performance Status (KPS) >70
6. Age>18
7. Male or Female (non-pregnant)
8. Life expectancy >6 months
9. Able to take oral medication
10. Able to provide informed consent

Exclusion Criteria

1. Subjects to be treated with other than SOC
2. Tumor invasion of bone (also see inclusion criteria)
3. Tumor classifications T1N0, T2N0, T4N3, any TN classification with M1
4. Tumors in locations other than those specified in inclusion criteria
5. Active peptic ulcer
6. Prior resection of jugular nodes ipsilateral to tumor
7. Acute or chronic viral, bacterial immune or other disease associated with abnormal immune function
8. Subjects on hemodialysis or peritoneal dialysis
9. History of asthma
10. Any condition that in the opinion of the investigator would cause the subject to be unable to participate or tolerate the protocol regimen

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS) in LI + CIZ + SOC vs. SOC <br>OS will be assessed using Kaplan-Meier life-table [From randomization up to 3 years ]<br>

Secondary Outcome Measures

Name	Time	Method
1. Progression Free Survival (PFS) in LI + CIZ + SOC vs.SOC <br>[PFS will be assessed using Kaplan-Meier life-table and compared using a logrank test ]<br><br>2. Local regional control (LRC) in LI + CIZ + SOC vs. SOC <br>[LRC will be assessed by classifying the first evidence of progression in local and distal sites for the control group and for the LI treated group]. <br><br>3. Quality of Life (QOL) in LI + CIZ + SOC vs. SOC <br>[QOL will be based on the EORTC QLOQ-C30 and EORTC QLQ-H&N35]. [From randomization up to 3 years]<br>