Using Tempol to reduce side effects from cancer treatments

A Double Blind, Placebo Controlled Dose Range Finding Study to Assess the Safety, Pharmacokinetics, and Efficacy of Tempol for the Reduction of Severe Mucositis in Head and Neck Cancer Patients Undergoing Combined Radio- and Chemotherapy

This study is testing if a drug called Tempol can help reduce side effects from cancer treatments like cisplatin and radiation in people with head and neck cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Matrix Biomed, Inc. (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 9 sites (La Jolla, California and 8 other locations)
• Trial ID: NCT03480971 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of Tempol in preventing or reducing toxicities associated with cisplatin and radiation therapy in patients with head and neck cancer. Over a 10-week period, 120 participants will be monitored for mucositis, nephrotoxicity, and ototoxicity, which are common side effects of these treatments. The study will compare the outcomes of those receiving Tempol against a placebo to determine its potential benefits in improving patient quality of life and treatment adherence.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of squamous cell cancer of the head and neck who are scheduled to receive cisplatin and radiotherapy.

Not a fit: Patients who are not receiving cisplatin or those with other types of head and neck cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients undergoing chemotherapy and radiation by reducing debilitating side effects.

How similar studies have performed: While the use of Tempol in this context is novel, similar studies have explored the use of antioxidants to mitigate chemotherapy side effects, showing promising results.

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.

Where this trial is running

La Jolla, California and 8 other locations

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

Study contacts

• Study coordinator: Benji Crane

Conditions: Mucositis, Nephrotoxicity, Ototoxicity, cisplatin toxicity