At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating LI, Cyclophosphamide, and 5 other interventions for Squamous Cell Carcinoma of the Oral Cavity and Squamous Cell Carcinoma of the Soft Palate. Completed, enrolled 928 participants across 102 sites in 23 countries.
Detailed Summary
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 Details
Timeline
Interventions
LI 400 IU (2.0mL total daily) 1.0 mL peritumoral, 1.0 mL perilymphatic 5x weekly x3 consecutive weeks administered as neoadjuvant therapy prior to SOC, (surgery followed by radiation or concurrent radiochemotherapy with cisplatin 100 mg/m\^2 intravenously x3) to determine if LI plus CIZ affects the 3-5 year overall survival.
Cyclophosphamide was administered IV bolus (one time only) at a dose of 300mg/m\^2 three days prior to beginning treatment with LI. Standard of care (SOC) for previously untreated squamous cell carcinoma of the head and neck is currently surgery followed by radiotherapy (60-70Gy in 30 to 35 fractions over 6 to 7 weeks) for higher risk subjects (subjects determined at surgery to have adverse features per the National Comprehensive Cancer Network (NCCN) guidelines, such as, positive surgical margins, 2 or more clinically positive nodes or extracapsular nodal spread, etc. that would pre-dispose them for higher risk of recurrence) radiotherapy is combined with concurrent chemotherapy (cisplatin 100mg/m\^2 intravenously on day 1 of weeks 1, 4 and 7 of radiotherapy.
One 25mg capsule of indomethacin was self administered orally (BID) beginning on day one of LI treatment daily until the day before surgery.
One capsule daily self administered beginning on day one of treatment with LI until one day before surgery
Excise tumor and nodes
Cisplatin was administered 100mg/m\^2 IV concurrent with radiotherapy. The chemotherapy agent (cisplatin 100mg/m\^2) was administered intravenously on day 1 of weeks 1, 4 and 7 of radiotherapy.
Total 60 to 70 Gy (2Gy per day) in 30 to 35 fractions over 6 to 7 weeks to subjects determined at surgery to be at lower risk for recurrence (per NCCN guidelines). For subjects determined at surgery to be at higher risk for recurrence due to having positive surgical margins, 2 or more clinically positive nodes or extracapsular nodal spread etc. (per NCCN guidelines), radiotherapy (as above) is combined with concurrent chemotherapy (cisplatin 100 mg/m\^2) intravenously on day 1 of weeks 1, 4 and 7 of radiotherapy.