BMX-001 for Head and Neck Cancer

Recruiting at 33 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NRG Oncology

Must be taking: Cisplatin

Must not be taking: Nitrates, Cytochrome P450 inducers

Disqualifiers: Metastatic disease, Cardiovascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

98 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

David M Brizel

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

This trial is for adults with squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity who are set to receive radiation and cisplatin chemotherapy. They must not have metastatic disease or be undergoing treatment for another unrelated cancer (with some exceptions). A good performance status and having at least two oral subsites receiving significant radiation are also required.

Inclusion Criteria

I am 18 years old or older.

My cancer is confirmed to be in my throat, mouth, or related areas.

My current diagnosis does not show any signs of cancer spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation Treatment

Participants receive cisplatin and undergo image-guided intensity-modulated radiation therapy for 7 weeks. In addition to usual symptom management, patients receive either BMX-001 or placebo subcutaneously.

7 weeks

5 visits per week (in-person)

Post-Treatment Monitoring

Participants are monitored for severe oral mucositis and other side effects, with assessments at 4, 6, 8, and 12 weeks after completion of treatment.

12 weeks

Follow-up

Participants are monitored for progression-free survival, overall survival, and other long-term outcomes.

24 months

Follow-up visits at 1, 2, 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• BMX-001

Trial Overview The trial tests if adding BMX-001 to standard symptom management reduces mouth sores caused by chemoradiation better than usual care alone in head and neck cancer patients. It involves comparing the effects of a radioprotector drug versus a placebo alongside various imaging techniques and questionnaires.

How Is the Trial Designed?

Group I: Arm 2 (BMX-001) Experimental Treatment 9 Interventions

Patients receive cisplatin QW or Q3W and undergo image-guided intensity-modulated radiation therapy QD 5 days per week for 7 weeks per SOC. In addition to usual symptom management, patients receive BMX-001 SC as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive BMX-001 SC BIW for 8 weeks (16 doses). Patients also undergo CT and/or MRI on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study.

Group II: Arm 1 (placebo) Placebo Group 9 Interventions

Patients receive cisplatin QW or Q3W and undergo image-guided intensity-modulated radiation therapy QD 5 days per week for 7 weeks per SOC. In addition to usual symptom management, patients receive placebo SC as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive placebo SC BIW for 8 weeks (16 doses). Patients also undergo CT and/or MRI on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+