A Phase III Study of the Effects of Multikine on Cancer of the Oral Cavity

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 880

Inclusion Criteria

Untreated tumors of the oral cavity to include ONLY the oral tongue (not the base of tongue), floor of mouth, cheek and soft palate that are scheduled for SOC (surgery and radiotherapy or surgery and concurrent chemo- radiotherapy).
Other key inclusions: primary tumor, and if present, clinically positive lymph node(s) measurable in two dimensions, normal immune function, no immunosuppressive drugs within the past year, Karnofsky Performance Status (KPS) = 70, age >18 yrs.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 270

Exclusion Criteria

1. Subjects other than those to be treated by surgery, followed by radiation therapy +/- chemotherapy and/or those for whom surgery would be scheduled prior to Day 8 from enrollment /randomization.
2. Tumor invasion of bone as detected by a suitable imaging technique MRI
and/or CT or by physical examination, except for mandibular invasion.
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).
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.