Treatment of Radiation and Cisplatin Induced Toxicities with Tempol

Prior treatment

• Prior radiotherapy of the head and neck;
• Be taking any non-approved therapy for oral mucositis, including β-carotene, tocopherol, laser irradiation, brushing the oral mucosa with silver-nitrate prophylactically, systemic TGF-β (transforming growth factor beta), or systemic KGF (keratinocyte growth factor) during or within 14 days of starting treatment;
• Have used an investigational drug within 28 days of the initiation of study treatment;
• Participants with a treatment plan consisting of chemoradiation followed by further chemotherapy;
• Participants with known intolerance to platin drugs;

Other illness

• Have a clinically significant infection defined as any acute viral, bacterial or fungal infection, which requires specific therapy. Anti-infectious therapy must have been completed within 14 days of starting study treatment;
• Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;
• Have a history of a positive blood test for HIV;
• At the time of screening, having a significant active medical illness which, in the opinion of the investigator, would preclude completion of the study;
• History of insulin-dependent Diabetes Mellitus; and
• Participants with Hepatitis B/C.

Other

• Be taking mugard;
• Be taking prostaglandins, pentoxifylline or leucovorin during or within 14 days of starting treatment;
• Be rinsing with allopurinol, hydrogen peroxide, sucralfate, or chlorhexidine mouthwashes during or within 14 days of starting treatment;
• Participants with body weight less than 35 kg, 77 lbs;
• Women who are pregnant or who are breastfeeding;

• Be ≥18 years of age with medically diagnosed squamous cell cancer of the head and neck (SCCHN);
• Be scheduled to receive radiotherapy or proton therapy administered with a curative intent;
• If female and of child bearing potential, be using an effective birth-control method with a history of reliability for the individual participant;
• If male and of child bearing potential, adequate methods of contraception must be employed including use of condoms with spermicide. No sperm donation for 90 days until after the conclusion of the study;
• Must be receiving cisplatin for chemotherapy;
• Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation;
• Must have a score 2 or less on the ECOG performance status;
• Participant life expectancy ≥ 6 months; and
• Adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):
  • Haematology:
  • Absolute neutrophil count (ANC) ≥1.5 Hemoglobin ≥ 10 g/dL Platelets ≥ 100,000 per microliter of blood
  • Hepatic:
  • Total bilirubin ≤ 2 X (Upper limit normal) ULN Alanine amino transferase (ALT) and Aspartate aminotransferase (AST) ≤5 x ULN
  • Renal:
  • Serum creatinine ≤ ULN or, if \> ULN calculated creatinine clearance (CrCl) ≥ 60 mL/min.
  • Nutritional and metabolic:
  • Urine Albumin \< 3.0 mg/dl