MnSOD Mimetic BMX-001 in Treating Patients with Anal Cancer Undergoing Radiation Therapy and Chemotherapy

Inclusion Criteria

• Patients with pathologically confirmed locally advanced anal squamous cell carcinoma (including oligometastatic disease) who will be receiving concurrent chemoradiation with standard 5FU/mitomycin regimen with curative intent
• Any cancer stage that will require a dose of 54.4 +/- 5.4 centigray (cGy)
• Age >= 19 years
• Eastern Cooperative Oncology Group (ECOG) >= 2
• Hemoglobin (Hgb) >= 9.0 g/dl; (the use of transfusion or other intervention to achieve Hgb > 9.0 g/dl is acceptable)
• Absolute neutrophil count (ANC) >= 1,500 /dl
• Platelets >= 100,000 /dl
• Serum creatinine =< 1.5 mg/dl
• Serum glutamic-oxaloacetic transaminase (SGOT) =< 1.5 times upper limit of normal
• Bilirubin =< 1.5 times upper limit of normal
• Signed, written informed consent
• Negative pregnancy test for women of child-bearing potential within 48 hours prior to first dose of BMX-001
• Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study and until 12 months following the last study treatment
• Positron emission tomography/ computed tomography (PET/CT)/ pelvic magnetic resonance imaging (MRI) done within 8 weeks of trial initiation

Exclusion Criteria

• Breast-feeding
• Active infection requiring intravenous (IV) antibiotics 7 days before enrollment
• Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell or carcinoma of the skin, invasive cancers with a 5-year disease-free interval, resected cancer of the bladder or low-grade (Gleason 6 or less) prostate cancer
• Prior history of ASCC
• Prior history of pelvic radiotherapy for any other type of malignancy
• Known hypersensitivity to 5FU and/or mitomycin
• Because corticosteroids are anti-inflammatory and could interrupt oxidative stress, patients will be required to be on stable or decreasing corticosteroids dose at the time of the study
• BMX-001 SPECIFIC EXCLUSION CRITERIA:
• Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
• Active or history of postural hypotension and autonomic dysfunction within the past year
• Known hypersensitivity to BMX-001
• Clinically significant (i.e. active) cardiovascular disease or cerebrovascular disease, for example cerebrovascular accidents =< 6 months prior to study enrollment, myocardial infarction =< 6 months prior to study enrollment, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment
• History or evidence upon physical/neurological examination of central nervous system disease (e.g. seizures) unrelated to cancer unless adequately controlled by medication or potentially interfering with protocol treatment
• Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment
• A marked baseline prolongation of QT/corrected QT (QTc) interval (e.g., repeated demonstration of a QTc interval > 480 milliseconds (ms) (Common Terminology Criteria for Adverse Events [CTCAE] grade 1) using the specific/usual choice by clinical center for correction factor
• A history of additional risk factors for Torsades de Pointes (TdP) (e.g., congestive heart failure, hypokalemia, known family history of long QT syndrome)