Treatment of Radiation and Cisplatin Induced Toxicities with Tempol

Launched by MATRIX BIOMED, INC. · Mar 27, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Tempol to see if it can help reduce side effects caused by chemotherapy and radiation in patients with head and neck cancer. The specific side effects being looked at are mucositis (painful inflammation in the mouth), nephrotoxicity (kidney damage), and ototoxicity (hearing loss). The trial will last for 10 weeks, during which participants will receive Tempol while undergoing treatment with cisplatin, a common chemotherapy drug, and radiation.

To be eligible for this trial, participants must be at least 18 years old, diagnosed with a specific type of head and neck cancer, and scheduled to receive radiation treatment alongside cisplatin. They should also be in generally good health with no recent serious infections or other significant medical issues. During the study, participants can expect regular check-ups to monitor any side effects and overall health. It's important to note that both men and women of child-bearing potential need to use effective birth control during the trial. If you or someone you know is interested in participating, it’s a good idea to discuss it with a healthcare provider to understand the potential benefits and risks.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Be ≥18 years of age with medically diagnosed squamous cell cancer of the head and neck (SCCHN);
• • 2. Be scheduled to receive radiotherapy or proton therapy administered with a curative intent;
• • 3. If female and of child bearing potential, be using an effective birth-control method with a history of reliability for the individual participant;
• • 4. 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;
• • 5. Must be receiving cisplatin for chemotherapy;
• • 6. 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;
• • 7. Must have a score 2 or less on the ECOG performance status;
• • 8. Participant life expectancy ≥ 6 months; and
• 9. 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
• Exclusion Criteria:
• • 1. Prior radiotherapy of the head and neck;
• • 2. 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;
• • 3. 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;
• • 4. Be taking mugard;
• • 5. Be taking prostaglandins, pentoxifylline or leucovorin during or within 14 days of starting treatment;
• • 6. Be rinsing with allopurinol, hydrogen peroxide, sucralfate, or chlorhexidine mouthwashes during or within 14 days of starting treatment;
• • 7. Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;
• • 8. Have used an investigational drug within 28 days of the initiation of study treatment;
• • 9. Have a history of a positive blood test for HIV;
• • 10. At the time of screening, having a significant active medical illness which, in the opinion of the investigator, would preclude completion of the study;
• • 11. Participants with a treatment plan consisting of chemoradiation followed by further chemotherapy;
• • 12. Participants with body weight less than 35 kg, 77 lbs;
• • 13. Women who are pregnant or who are breastfeeding;
• • 14. Participants with known intolerance to platin drugs;
• • 15. History of insulin-dependent Diabetes Mellitus; and
• • 16. Participants with Hepatitis B/C.