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RECRUITING

NCT06532279

PHASE2

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

Sponsor: NRG Oncology

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-12-16

Completion Date

2027-01-01

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Interventions

OTHER

Best Practice

Receive usual symptom management

PROCEDURE

Biospecimen Collection

Undergo collection of blood, serum, and/or plasma samples

DRUG

Cisplatin

Given cisplatin

PROCEDURE

Computed Tomography

Undergo CT

RADIATION

Image Guided Radiation Therapy

Undergo image-guided radiation therapy

RADIATION

Intensity-Modulated Radiation Therapy

Undergo intensity-modulated radiation therapy

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

MnSOD Mimetic BMX-001

Given SC

DRUG

Placebo Administration

Given SC

OTHER

Questionnaire Administration

Ancillary studies

Inclusion Criteria: * 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). * No valvular heart disease. * No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment. * No history or evidence upon physical/neurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication. * No acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days of enrollment. * No history of chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration. * No known personal or family history of long QT Syndrome; no marked baseline prolongation of QT/corrected QT (QTc) interval (i.e., ≥ 2 electrocardiograms \[EKGs\] in prior 3 months of a QTc interval \> 450 milliseconds (ms) for males and \> 470 ms for females using the specific/usual choice by clinical center for correction factor. * Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities must be reversible to ≤ grade 1 with supplementation. * No poorly controlled hypertension (systolic blood pressure \[SBP\] \> 160 and/or diastolic blood pressure \[DBP\] \> 95) over 2 repeated measures within 30 days prior to registration. * No grade \>= 2 oral mucositis per CTCAE version 5.0. * No grade \>= 2 hypotension per CTCAE v. 5.0. * No medical necessity for anti-arrhythmics with significant risk of QTc prolongation such as class I and class III anti-arrhythmics. These include but are not limited to amiodarone, quinidine, dofetilide, sotalol, flecainide, and lidocaine. * No medical necessity for medications listed as prohibited. * For standard management of oral mucositis, clinicians may consult the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. The only intervention against mucositis that is supported by level I evidence is low-level laser therapy (LLLT). Honey is rated at level II and benzydamine, which isn't available in the United States (US), is rated at level III. There are no other positively rated interventions. * LLLT is prohibited in this study as its availability remains limited, it is not Food and Drug Administration (FDA) approved in the US, and it is considered investigational in many circumstances requiring enrollment in a dedicated protocol who requirements could conflict with this one. Therefore, institutions that use LLLT should only enroll patients who would not be eligible for (or do not want) that intervention. Honey is not on the list of prohibited medications for this study. Given the MASCC recommendation, benzydamine is allowed, although there is lack of availability in the United States of America (USA). The other listed prohibited medications are not recommended by MASCC and some are potentially harmful, such as glutamine, which is associated with mortality in patients receiving stem cell transplant. * No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients). * Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.

Locations (149)

Arizona Center for Cancer Care - Gilbert

Gilbert, Arizona, United States

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, United States

Arizona Center for Cancer Care - Phoenix

Phoenix, Arizona, United States

Arizona Center for Cancer Care - Scottsdale

Scottsdale, Arizona, United States

Arizona Center for Cancer Care-Surprise

Surprise, Arizona, United States

Arizona Center for Cancer Care

Tempe, Arizona, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

Keck Medicine of USC Buena Park

Buena Park, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

Shaw Cancer Center

Edwards, Colorado, United States

George Washington University Medical Center

Washington D.C., District of Columbia, United States

Sarasota Memorial Hospital-Venice

N. Venice, Florida, United States

Moffitt Cancer Center at SouthShore

Ruskin, Florida, United States

Florida Cancer Specialists - Sarasota

Sarasota, Florida, United States

Florida Cancer Specialists - Sarasota Downtown

Sarasota, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Sarasota Memorial Health Care Center at University Parkway

Sarasota, Florida, United States

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Florida Cancer Specialists - Venice Pinebrook

Venice, Florida, United States

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States

OSF Saint Joseph Medical Center

Bloomington, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Illinois CancerCare - Washington

Washington, Illinois, United States

McFarland Clinic - Ames

Ames, Iowa, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Mercy Hospital

Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Salina Regional Health Center

Salina, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Baptist Health Hardin

Elizabethtown, Kentucky, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

McLaren Cancer Institute-Bay City

Bay City, Michigan, United States

McLaren Cancer Institute-Clarkston

Clarkston, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, United States

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

McLaren-Port Huron

Port Huron, Michigan, United States

Miller-Dwan Hospital

Duluth, Minnesota, United States

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, United States

Baptist Cancer Center-Grenada

Grenada, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Lake Regional Hospital

Osage Beach, Missouri, United States

Renown Regional Medical Center

Reno, Nevada, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Atrium Health Stanly/LCI-Albemarle

Albemarle, North Carolina, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, United States

Atrium Health University City/LCI-University

Charlotte, North Carolina, United States

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

CaroMont Regional Medical Center

Gastonia, North Carolina, United States

Levine Cancer Institute-Gaston

Gastonia, North Carolina, United States

Hayworth Cancer Center

High Point, North Carolina, United States

Atrium Health Union/LCI-Union

Monroe, North Carolina, United States

Atrium Health Cleveland/LCI-Cleveland

Shelby, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Summa Health System - Akron Campus

Akron, Ohio, United States

Aultman Health Foundation

Canton, Ohio, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Chambersburg Hospital

Chambersburg, Pennsylvania, United States

Ephrata Cancer Center

Ephrata, Pennsylvania, United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, United States

Adams Cancer Center

Gettysburg, Pennsylvania, United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Sechler Family Cancer Center

Lebanon, Pennsylvania, United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, United States

UPMC Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

UPMC Hillman Cancer Center - New Castle

New Castle, Pennsylvania, United States

UPMC-Saint Margaret