What is BMX-001 studying for head and neck cancer?

BMX-001 is being studied to see if adding it to usual symptom management reduces oral mucositis in patients receiving chemoradiation for head and neck cancer. Researchers want to compare how often severe mouth sores occur and how long they last. The study is sponsored by NRG Oncology and aims to improve symptom control during treatment.

Who may be eligible for this head and neck cancer clinical trial?

Adults aged 18 or older with confirmed squamous cell carcinoma of the head and neck who are planned to receive radiation and concurrent cisplatin chemotherapy may be eligible. Participants must not have prior overlapping radiation or current severe oral mucositis. Please review eligibility criteria for more details.

Is there any cost to participate in this head and neck cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can plan for study visits and treatments without paying for the trial procedures.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06532279

Comparing BMX-001 to Placebo with Usual Chemoradiation Therapy for Reducing Oral Mucositis in Head and Neck Squamous Cell Carcinoma

Led by NRG Oncology · Updated on 2026-06-25

Participants Needed

153

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the addition of BMX-001 to usual symptom management compared to usual symptom management alone to reduce oral mucositis in patients receiving chemoradiation for head and neck cancer. Oral mucositis, which causes inflammation and mouth sores, is a common side effect of chemoradiation that can lead to pain and difficulty swallowing. This phase II trial aims to compare the incidence and duration of severe oral mucositis, as well as other side effects like xerostomia and radiation dermatitis, between the two treatment groups. Participants are randomly assigned to one of two groups. Both receive cisplatin chemotherapy once weekly or every three weeks and undergo image-guided intensity-modulated radiation therapy daily for seven weeks. In addition to usual symptom management, one group receives placebo injections subcutaneously twice a week for eight weeks, while the other group receives BMX-001 injections on the same schedule. Imaging such as CT and MRI scans and optional blood, serum, or plasma collection occur during the study. Throughout the trial, participants complete questionnaires and are monitored for side effects, toxicities, and oral mucositis severity up to 24 months after completing treatment. Follow-up visits occur at 1, 2, 3, 6, 12, and 24 months. Researchers assess patient-reported symptoms, duration of oral mucositis, radiation dermatitis, and overall survival outcomes. The trial also collects biological samples for future research.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy
At least two oral subsites must receive 50 Gy or more radiation dose
Confirmed squamous cell carcinoma of oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity
Documented p16 and/or HPV status for oropharynx cancer patients
No T0/Tx/unknown primary disease
No clinical or radiologic evidence of metastatic disease
Able to receive intensity-modulated radiation therapy daily with cumulative dose of 70 Gy
Age 18 years or older
Zubrod performance status 0 to 2
Potassium and magnesium levels at or above institutional lower limits
Absolute neutrophil count 1,500 cells/mm³ or higher
Platelets 100,000 cells/mm³ or higher
Hemoglobin 9.0 g/dl or higher (transfusion allowed to achieve 10.0 g/dl)
Adequate renal function with creatinine clearance above 50 mL/min
Total bilirubin not more than twice the upper limit of normal (except Gilbert's syndrome)
AST and ALT not more than three times upper limit of normal
No prior radiotherapy overlapping treatment fields
No concurrent treatment with nitrates or drugs risking blood pressure drops
No gross total excision of both primary and nodal disease
No current adjuvant post-operative chemoradiation
No systemic treatment with inducers or strong inhibitors of cytochrome P450 within 4 days before registration
No prior induction chemotherapy treatment
No prior unrelated malignancy requiring active treatment (exceptions apply)
No significant hearing impairment precluding cisplatin
No serious cardiovascular or cerebrovascular disease in past 6 months
No valvular heart disease
No significant vascular disease in past 6 months
No central nervous system disease unrelated to cancer unless controlled
No acute infection requiring IV antimicrobials within 7 days
No respiratory illness requiring hospitalization within 30 days
No personal or family history of long QT syndrome or prolonged QTc
Reversible grade 3-4 electrolyte abnormalities
No poorly controlled hypertension
No grade 2 or higher oral mucositis
No grade 2 or higher hypotension
No need for certain anti-arrhythmic medications
No allergy to study agents or similar compounds
Childbearing potential defined with specific criteria

You will not qualify if you...

Planned concurrent cisplatin and radiation therapy in the adjuvant setting
Prior radiotherapy overlapping planned treatment fields
Concurrent treatment with nitrates or drugs risking blood pressure drops
Prior gross total excision of both primary and nodal disease
Current treatment of adjuvant post-operative chemoradiation
Systemic treatment with inducers or strong inhibitors of cytochrome P450 within 4 days before registration
Prior induction chemotherapy treatment
Prior unrelated malignancy requiring active treatment (exceptions apply)
Clinically significant hearing impairment precluding cisplatin
Serious cardiovascular or cerebrovascular disease in past 6 months
Valvular heart disease
Significant vascular disease in past 6 months
Central nervous system disease unrelated to cancer unless controlled
Acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days
Chronic obstructive pulmonary disease exacerbation or respiratory illness requiring hospitalization within 30 days
Personal or family history of long QT syndrome or prolonged QTc
Persistent grade 3-4 electrolyte abnormalities not reversible to grade 1
Poorly controlled hypertension
Grade 2 or higher oral mucositis
Grade 2 or higher hypotension
Medical necessity for certain anti-arrhythmic medications
History of allergic reaction to study agents or similar compounds

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Comparing BMX-001 to Placebo with Usual Chemoradiation Therapy for Reducing Oral Mucositis in Head and Neck Squamous Cell Carcinoma

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria