Treatment of Radiation and Cisplatin Induced Toxicities with Tempol

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Mucositis, Nephrotoxicity, Ototoxicity

In brief

A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients. Over the course of the 10 week trial, mucositis, nephrotoxicity, and ototoxicity will be monitored and assessed.

Key facts

Study ID

NCT03480971

Run by

Matrix Biomed, Inc.

People needed

120

Starts

2019-05-13

Expected to finish

2025-12-01

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior radiotherapy of the head and neck;
• 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;
• 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;
• 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;
• Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;
• Have used an investigational drug within 28 days of the initiation of study treatment;
• 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;
• Participants with a treatment plan consisting of chemoradiation followed by further chemotherapy;
• Participants with body weight less than 35 kg, 77 lbs;
• Women who are pregnant or who are breastfeeding;
• Participants with known intolerance to platin drugs;
• History of insulin-dependent Diabetes Mellitus; and
• Participants with Hepatitis B/C.

Where it is running

• University of Washington Medical Center — Seattle, Washington, United States (enrolling)
• Mercy Medical Center — Merced, California, United States (enrolling)
• UCSD — La Jolla, California, United States (enrolling)
• Central Coast Medical Oncology — Santa Maria, California, United States (enrolling)
• Mission Hope Health Center — Santa Maria, California, United States (enrolling)
• Montefiore Medical Center-Einstein Campus — The Bronx, New York, United States (enrolling)
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)
• Seattle Cancer Care Alliance — Seattle, Washington, United States (enrolling)
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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