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

• Register: SLCTR
• Last refreshed on: 29 April 2024
• Main ID: SLCTR/2014/017
• Date of registration: 2014-08-25
• Prospective Registration: Yes
• Primary sponsor: Dr. E Talor
• Public title: Efficacy and Safety Study of Leukocyte Interleukin, Injection (LI) to Treat Cancer of the Oral Cavity
• Scientific title: A Phase III, Open-label, Randomized, Multi-center Study of the Effects of Leukocyte Interleukin, Injection [Multikine] Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity / Soft Palate Versus Standard of Care Only
• Date of first enrolment: 2014-08-25
• Target sample size: Global 880; Sri Lanka 300
• Recruitment status: Complete: follow up complete
• URL: https://slctr.lk/trials/slctr-2014-017
• Study type: Interventional
• Study design: Randomized controlled trial
• Phase: Phase 3

Countries of recruitment

Canada,Croatia,Hungary,India,Israel,Poland,Russian Federation,Serbia,Sri Lanka,Taiwan, Province of China,Ukraine,United States

Contacts

• Name: Dr Prasad Abeysinghe/ Principal Investigator
• Affiliation: Consultant Clinical Oncologist

• Name: Dr Prasad Abeysinghe/ Principal Investigator
• Affiliation: Consultant Clinical Oncologist

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Squamous Cell Carcinoma of the Oral Cavity and soft palate

Intervention(s)

Interventions will be as follows
1. Leukocyte Interleukin (Multikine): 400IU Multikine (2.0mL total daily) 1.0 mL peritumoral, 1.0 mL perilymphatic will be administered 5 times a week for 3 weeks

2. Cyclophosphamide, indomethacin and zinc (CIZ treatment)
• Cyclophosphamide 300mg/m2 (IV bolus) 3 days prior to treatment with Multikine
• Indomethacin 25mg capsules t.i.d., from day 1 of Multikine treatment up to 1 day prior to surgery
• Daily zinc supplementation as found in a standard multivitamin formulation (> or = to 15mg but not > 40mg) from day 1 of Multikine treatment up to 1 day prior to surgery

3. Standard of care (SOC): surgery of tumor and involved lymph nodes + radiotherapy or surgery + concurrent chemoradiotherapy

The participants will be randomized into 3 arms
Arm 1 : Leukocyte Interleukin (Multikine) + cyclophosphamide, indomethacin and zinc (CIZ) + Standard of care (SOC)
Arm 2 : Multikine + SOC
Arm 3 : SOC only

Primary Outcome(s)

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

Secondary Outcome(s)

1. Progression Free Survival (PFS) in LI + CIZ + SOC vs.SOC
[PFS will be assessed using Kaplan-Meier life-table and compared using a logrank test ]

2. Local regional control (LRC) in LI + CIZ + SOC vs. SOC
[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].

3. Quality of Life (QOL) in LI + CIZ + SOC vs. SOC
[QOL will be based on the EORTC QLOQ-C30 and EORTC QLQ-H&N35]. [From randomization up to 3 years]

Source(s) of Monetary Support

CEL-SCI Corporation, USA

Secondary Sponsor(s)

J Cipriano

Ethics review

Status: Approved
Approval date: 11/03/2014
Contact:

[e-mail]

Ethics Review Committee, Faculty of Medicine, University of Kelaniya

[phone]

[e-mail]