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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01265849.
Head and neck carcinomas constitute about 5% of all cancers annually worldwide. In the US
there are about 65,000 new cases annually. Ninety percent are squamous cell carcinoma of
the head and neck (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 concurrent radiochemotherapy - is estimated to be between 52 and 55%; the
5 year OS is approximately 43%. There are clearly many 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 I and Phase II clinical trials. LI is 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 was 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 arm]. OS is the
primary efficacy endpoint.
Lead OrganizationCEL-SCI Corporation
