Subjects with Advanced Primary Sqamous Cell Carcinoma of the oral Cavity/Soft Palate
Conditions
Interventions
Product Name: Leukocyte Interleukin, Injection
Product Code: Multikine
Pharmaceutical Form: Injection
INN or Proposed INN: Leukocyte Interleukin Injection (LI), Bulk solution
Current Sponsor code: Mul
Sponsors
CEL-SCI Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Previously untreated primary squamous cell carcinoma of the oral cavity inclusive of the tongue (but not the base of the tongue), floor of the mouth, cheek (buccal mucosa) and soft palate only, confirmed by biopsy, with or without regional lymph nodal metastases, deemed curable by and scheduled for definitive treatment by surgical resection and postoperative radiation therapy or surgical resection and postoperative concurrent chemoradiotherapy (standard of care). Tumors in other locations (and those in other locations of the head and neck) are excluded. • The primary tumor class must be T1, T2 or T3 and must NOT measure more than 6 cm in greatest dimension. T4 is allowed if invasion of the mandible is minimal (defined as 9gm/dL; WBC: > 3000/mm3; platelets: > 100,000/mm3, bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 127
Exclusion criteria
Exclusion criteria: 1. Subjects other than those to be treated by surgery, followed by radiation therapy +/- chemotherapy. 2. Tumor invasion of bone as detected by a suitable imaging technique MRI and/or CT or by physical examination, except for mandibular invasion (as described above for T4 Tumor). 3. Any T1N0 or T2N0 stage tumors and all tumors classified as T4, N3 and/or any TN classification with M1 or greater (Note: only M0 is allowed in this study), or in locations other than those specified in Inclusion Criteria #1 (Section 4.1). 4. Active peptic ulcer disease despite ongoing adequate medical therapy. 5. Prior surgical resection of the jugular lymph nodes on the ipsilateral neck that the injection is to be administered. 6. Any acute or chronic viral, bacterial, immune or other disease in a stage usually associated with abnormal cellular immunity (e.g., HIV infection, hepatitis, nephritis, lung disease, rheumatoid arthritis or other autoimmune disease). 7. Subjects on hemodialysis or peritoneal dialysis. 8. Prior history of asthma. 9. Prior completion of one or more courses of therapeutic irradiation, excluding such treatment of the extremities. 10. History of allergic reaction to fluoroquinolone antibiotics (e.g., ciprofloxacin, ofloxacin). 11. History of any other malignancy, excluding basal cell carcinoma of the skin and in-situ carcinoma of the cervix. 12. History of congestive heart failure (CHF) and other heart conditions that in the opinion of the investigator would cause the subject to likely be unable to participate in the study or tolerate the study’s protocol regimen (including the surgical procedure). 13. The opinion of the investigator that the subject may be unable to tolerate the protocol regimen or that participation in the trial may compromise the subject’s preparation for tumor treatment . 14. Failure to meet the Inclusion Criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the efficacy of peri-tumoral and peri-lymphatic injection of Multikine (400 IU, as IL-2) plus CIZ given prior to Standard of Care (SOC) as measured by overall survival. ;Secondary Objective: The secondary objectives are to evaluate the effects of Multikine plus CIZ treatment on the cumulative incidence of locoregional control, progression-free survival, tumor response, tumor histopathology, and quality of life, while confirming Multikine safety.;Primary end point(s): The primary endpoint of the study is Overall Survival. After Multikine injection (with or without Cyclophosphamide, Indomethacin and Zinc ) followed by Standard of Care treatment, subjects will be monitored on a regular basis by clinical and radiographic criteria and will be followed for 36-48 months after completion of study drug + Standard of Care until the required number of deaths are observed. The SOC group will also be followed.;Timepoint(s) of evaluation of this end point: After Multikine injection (with or without CIZ) followed by SOC treatment, subjects will be monitored on a regular basis by clinical and radiographic criteria and will be followed for 36-48 months after completion of study drug + SOC until the required number of deaths are observed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Progression-free survival (defined as survival without tumor recurrence, new disease or distant metastases) and on the rate and distribution of distant metastases. 2.Disease progression defined as loco-regional failure, i.e. the reappearance (recurrence) of disease, progressive disease (but not distant metastases), or any new disease above the clavicle not present at baseline. 3.Quality of life assessments on subjects receiving Multikine treatment and standard of care. 4.Histopathological nature of cellular tumor infiltration stimulated by Multikine injection.;Timepoint(s) of evaluation of this end point: Throughout the study and until up to 4 years after the study | — |
Countries
Austria, Belarus, Bosnia and Herzegovina, Canada, Croatia, France, Germany, Hungary, India, Israel, Italy, Poland, Romania, Russian Federation, Serbia, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactJohn Cipriano
CEL-SCI Corporation
Outcome results
None listed