Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In this Phase 1/2 study, the investigators will conduct a safety and efficacy study of the combination of BMX-001 with standard radiation therapy (RT) and concurrent 5-fluorouracil (5FU)/mitomycin in newly diagnosed Anal Squamous Cell Carcinoma (ASCC) patients. The primary objectives are: Phase 1 - is to determine the maximum tolerated dose (MTD) of BMX-001 in ASCC patients receiving RT and concurrent 5FU/mitomycin chemotherapy.2. For phase II part: To examine the impact of BMX-001 on the overall acute ≥ grade 3 toxicity rate of the normal tissue including rectum, bladder, and skin in combination with RT and concurrent 5FU/mitomycin in treatment of newly diagnosed ASCC patients

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chi Lin, MD, PhD
• Collaborators: BioMimetix JV, LLC; University of Nebraska
• Treatments: Manganese

Criteria

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 59.4 cGy.

• Age ≥ 19 years

• Karnofsky Performance Status (KPS) ≥ 60%

• Hemoglobin ≥ 9.0 g/dl, ANC ≥ 1,500 /dl, platelets ≥ 100,000 /dl (The use of transfusion or other intervention to achieve Hgb > 9.0 g/dl is acceptable)

• Serum creatinine ≤ 1.5 mg/dl, serum SGOT and 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

• PET/CT/ pelvic MRI done within 8 weeks of trial initiation

Exclusion Criteria:

• Breast-feeding

• Active infection requiring 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.

• 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/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (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).