A Randomized Phase-2 Trial to Evaluate the Effects of the IRX-2 Regimen before Surgery and after Chemotherapy or Radiation in Newly Diagnosed Patients with Stage II, III or IVA Squamous Cell Cancer of the Oral Cavity

Phase 1

Conditions: ewly Diagnosed Stage II, III or IVA Squamous Cell Carcinoma of the Oral Cavity.
MedDRA version: 20.0Level: PTClassification code 10041857Term: Squamous cell carcinoma of the oral cavitySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-000373-21-HU

Lead Sponsor: IRX Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. Pathologically confirmed diagnosis of Stage II, III or IVA squamous cell cancer of the oral cavity (excluding the lip). Staging must be done using AJCC Cancer Staging Manual Edition 7.0.
2. Subjects: males or females at least 18 years of age at study entry.
3. Disease is surgically resectable with a curative intent.
4. Karnofsky Performance Status = 70%.
5. Haematological, Hepatic and Renal functions are adequate for surgical intervention.
6. Females of child-bearing potential must have negative urine/serum pregnancy test and agree to used a highly effective form of birth control.
7. Subjects are able to give Informed Consent and adhere to the protocol treatment plan.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. Prior surgery, radiation or chemotherapy (excluding biopsy or any procedure required for supportive care).
2. Tumour of the oropharynx.
3. Tumour involvement likely to be associated with T4b cancer.
4. Distant metastased (M1 disease).
5. Diagnosis of another invasive cancer which is currently not in remission and has required treatment within the last 5 years.
6. Known infection with hepatitis B, C or HIV.
7. Use of any Investigational agent within 30 days of randomization.
8. Symptomatic cardiopulmonary disease which are not clinical stable.
9. Myocardial infarction within the last 3 months.
10. Stroke or other cerebral vascular insufficiency within last 3 months.
11. Daily use systemic immunosuppressive therapy or corticosteroids (except for hormone deficiency) 30 days prior to randomization.
12. Known allergies to ciprofloxacin(or other quinolones) acetylsalicylic acid or indomethacin.