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Phase III Study of LI [Multikine®] Plus SOC (Surgery + Radiotherapy or Surgery + Concurrent Radiochemotherapy) in Subjects With Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate vs. SOC Only

Phase 3
18 Years
Open (Enrolling)
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Soft Palate

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Trial Information

Phase III Study of LI [Multikine®] Plus SOC (Surgery + Radiotherapy or Surgery + Concurrent Radiochemotherapy) in Subjects With Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate vs. SOC Only

Head and neck carcinomas constitute about 5% of all cancers annually worldwide. In the US
there are about 37,000 new cases annually. Ninety percent are advanced primary squamous cell
carcinoma (SCCHN). Approximately 2/3 of SCCHN patients present on their first visit with
locally advanced disease. The median 3 year overall survival(OS) for these patients with
existing standard of care (SOC) therapies - surgery followed by radiotherapy or combined
radiochemotherapy - is between 52 and 55%; the 5 year OS is 43%. There are clearly a large
number of SCCHN patients not well served by available modalities.

Regional intra or perilymphatic and/or intratumoral or peritumoral low dose cytokine therapy
may have important therapeutic effects in SCCHN patients and constitute an additional
anti-tumor mechanism of action different and distinct from current SOC. Leukocyte
Interleukin Injection (LI) [Multikine]contains a defined mixture of naturally derived
cytokines and chemokines with demonstrated safety and immunomodulatory activity in animals
and in man in Phase 1 and 2 clinical trials. LI was administered prior to SOC and in
combination with low non-chemotherapeutic doses of cyclophosphamide, indomethacin, and zinc
(CIZ) in studies with LI. The results of these studies indicate that the local/regional
injection of mixed interleukins (LI) with CIZ prior to SOC can overcome local
immunosuppression, break tumor tolerance to tumor antigens and allow for a sustainable and
effective anti-tumor immune response.

LI is being tested in this large, global, multinational Phase III clinical trial to develop
definitive proof of its efficacy and safety in treating SCCHN. The trial is an open-label
randomized multi-center controlled study of LI + CIZ + SOC in subjects with advanced primary
SCCHN of the oral cavity/soft palate vs. SOC [The Comparator Arms for, Overall Survival, the
Primary End Point of this Study].

Inclusion Criteria:

- 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

- Primary tumor and any positive node(s)measurable in 2 dimensions

- normal immune function

- no immunosuppressives with 1 year

- KPS>70

- Age>18

- Male or Female (non-pregnant)

- Life expectancy >6mo.

- Able to take oral medication

- Able to provide informed consent

Exclusion Criteria:

- 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

- 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

- History of asthma

- Any condition that in the opinion of the investigator would cause the subject to be
unable to participate or tolerate the protocol regimen

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS) in LI + CIZ + SOC vs. SOC

Outcome Description:

OS will be assessed using Kaplan-Meier life-table and compared using a logrank test and confirmed further with tumor stage location and geographic stratified log rank tests. The unstratified logrank test constitutes the primary analysis. A two-sided p-value of 0.05 or less will be considered statistically significant for comparing the two groups. Interim analyses will be performed throughout the study to assess safety, sample size and futility.

Outcome Time Frame:

3 year

Safety Issue:


Principal Investigator

Eyal Talor, PhD

Investigator Role:

Study Director

Investigator Affiliation:

CEL-SCI Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

December 2017

Related Keywords:

  • Squamous Cell Carcinoma of the Oral Cavity
  • Squamous Cell Carcinoma of the Soft Palate
  • Carcinoma
  • Carcinoma, Squamous Cell



North Mississippi Health ServicesTupelo, Mississippi  38801
NJ Medical School VA NJ HealthcareEast Orange, New Jersey  07018