Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Nasopharyngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Stage 0 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage 0 Hypopharyngeal Carcinoma AJCC v8, Stage 0 Nasopharyngeal Carcinoma AJCC v8, Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage I Hypopharyngeal Carcinoma AJCC v8, Stage I Laryngeal Cancer AJCC v8, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage I Nasopharyngeal Carcinoma AJCC v8, Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage II Hypopharyngeal Carcinoma AJCC v8, Stage II Laryngeal Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Stage II Nasopharyngeal Carcinoma AJCC v8, Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Nasopharyngeal Carcinoma AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Hypopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Lip and Oral Cavity Cancer AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stomatitis

In brief

This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.

Key facts

Study ID

NCT06532279

Run by

NRG Oncology

People needed

98

Starts

2025-06-23

Expected to finish

2027-01-01

Last updated by the study team

2026-06-25

Who can join

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

You may qualify if…

• Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.
• At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving >= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving >= 50 Gy must be documented by the enrolling physician.
• Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.
• P16 and/or human papillomavirus (HPV) status (via polymerase chain reaction [PCR] or in situ hybridization [ISH]) must be documented for patients with oropharynx cancer.
• No patients with T0/Tx/unknown primary disease.
• No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.
• Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.
• Age >= 18.
• Zubrod performance status of 0-2.
• Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.
• Absolute neutrophil count (ANC) >= 1,500 cells/mm\^3.
• Platelets >= 100,000 cells/mm\^3.
• Hemoglobin >= 9.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable).
• Adequate renal function defined as creatinine clearance (CrCL) > 50 mL/min by the Cockcroft-Gault formula.
• Total bilirubin =< 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome).
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN.
• No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa/level 4 neck.
• No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.
• No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.
• No current treatment of adjuvant post-operative (op) chemoradiation.
• No systemic treatment with inducers or strong inhibitors of cytochrome P450 =< 4 days before registration. Note: Patients undergoing steroid treatment as a component of the anti-emetic regimen for cisplatin are eligible for the study. Treatment with the antifungal medications, nystatin, fluconazole , miconazole and clotrimazole are allowed.
• No prior induction chemotherapy treatment.
• No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low risk prostate cancer.
• No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.
• No serious cardiovascular disease or cerebrovascular disease in the last 6 months prior to study enrollment; defined as a cerebrovascular accident, myocardial infarction, unstable angina, serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment, or current New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or admission within last 6 months for CHF exacerbation; (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification).

Where it is running

• Florida Cancer Specialists - Venice Pinebrook — Venice, Florida, United States (enrolling)
• OSF Saint Joseph Medical Center — Bloomington, Illinois, United States (enrolling)
• Arizona Center for Cancer Care-Peoria — Peoria, Arizona, United States (enrolling)
• Arizona Center for Cancer Care - Gilbert — Gilbert, Arizona, United States (enrolling)
• Moffitt Cancer Center at Wesley Chapel — Wesley Chapel, Florida, United States (enrolling)
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States (enrolling)
• Arizona Center for Cancer Care - Scottsdale — Scottsdale, Arizona, United States (enrolling)
• UC San Diego Health System - Encinitas — Encinitas, California, United States (enrolling)
• UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• Arizona Center for Cancer Care-Surprise — Surprise, Arizona, United States (enrolling)
• Arizona Center for Cancer Care — Tempe, Arizona, United States (enrolling)
• Arizona Center for Cancer Care - Phoenix — Phoenix, Arizona, United States (enrolling)
• UC San Diego Medical Center - Hillcrest — San Diego, California, United States (enrolling)
• Shaw Cancer Center — Edwards, Colorado, United States (enrolling)
• George Washington University Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Sarasota Memorial Hospital-Venice — N. Venice, Florida, United States (enrolling)
• Moffitt Cancer Center at SouthShore — Ruskin, Florida, United States (enrolling)
• Florida Cancer Specialists - Sarasota — Sarasota, Florida, United States (enrolling)
• Florida Cancer Specialists - Sarasota Downtown — Sarasota, Florida, United States (enrolling)
• Sarasota Memorial Hospital — Sarasota, Florida, United States (enrolling)
• Sarasota Memorial Health Care Center at University Parkway — Sarasota, Florida, United States (enrolling)
• Moffitt Cancer Center-International Plaza — Tampa, Florida, United States (enrolling)
• Moffitt Cancer Center - McKinley Campus — Tampa, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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