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Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 880

Inclusion Criteria

1. 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 <0.5cm as confirmed by CT, and/or MRI with the use of CT imaging being mandatory) and can be salvaged by marginal mandiblectomy (retention of function and having intact mandible post surgery).
- The class of clinically positive lymph node(s) must be N1 or N2 and must not measure more than 6 cm in greatest dimension.
- Clinical tumor stage must be III or IV. For stage IV, only subjects treatable by surgical resection or surgical resection followed by postoperative radiation/ radiochemotherapy are eligible:
Eligible TNM Categories:
T1 N1-2 M0
T2 N1-2 M0
T3 N0-2 M0
T4* N0-2, M0
* T4 is allowed if invasion of the mandible is minimal (defined as <0.5cm as confirmed by CT, and or MRI with
CT imaging mandatory) and can be salvaged by marginal mandiblectomy (retention of function and having intact mandible post surgery).

2. Primary tumor and, if present, clinically positive lymph node(s) with at least one measurable lesion as defined
by the RECIST criteria (Appendix 10) and measurable in two dimensions by physical examination.
3. ?18 years of age.
4. If female, is neither pregnant nor lactating.
5. If subject is of reproductive potential they must be willing and able to utilize effective methods of contraception (e.g. barrier methods with spermicide).
6. Hemoglobin: >9gm/dL; WBC: > 3000/mm3; platelets: > 100,000/mm3, bilirubin < 1.0 mg/dL; creatinine < 1.2 mg/dL.
7. No prior therapy with IL-2, IL-1 or any other biological response modifier in past one year.
8. Negative reaction to intradermal test with ciprofloxacin (a fluoroquinolone antibiotic).
9. No immune depressive drugs, e.g., corticosteroids, cyclosporine, methotrexate, or anticancer agents, in past one year. Subjects on topical corticosteroids to treat dermatological conditions covering not more than 5% of body surface area are considered eligible.
10. Life expectancy greater than six months.
11. Karnofsky score 70 or greater.
12. Able to take oral medication.
13. Able to provide informed consent.
14. Must have normal immune function, i.e., must not be known to be HIV infected or have any other disease or condition causing significant immunodeficiency.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 784
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 784

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 (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. Prior history of and treatment for peptic ulcer with ongoing evidence of peptic ulcer.
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.