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

Trial Status: Closed to Accrual

The purpose of this study is to determine whether LI administered in combination with cyclophosphamide, indomethacin and zinc (CIZ) in a multivitamin 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 squamous cell carcinoma of the oral cavity or soft palate at a median of 3 years

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


UC Irvine Health / Chao Family Comprehensive Cancer Center
Contact: Samuel Ejadi
Phone: 877-827-8839


University of Minnesota / Masonic Cancer Center

South Carolina

Medical University of South Carolina

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


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].

Trial Phase Phase III

Trial Type Treatment

Lead Organization
CEL-SCI Corporation

  • Primary ID CS001P3
  • Secondary IDs NCI-2014-01668, 2010-019952-35
  • ID NCT01265849