Status:
ACTIVE_NOT_RECRUITING
Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
BioMimetix JV, LLC
Conditions:
Anal Cancer, Squamous Cell Carcinoma
Radiation Exposure
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
Over 80% of anal cancers are squamous cell carcinoma (SCC). Current standard treatment for locally advanced squamous cell carcinoma of the anal canal is a combination of radiation therapy (RT) and con...
Detailed Description
Over 80% of anal cancers are squamous cell carcinoma (SCC). Current standard treatment for locally advanced squamous cell carcinoma of the anal canal is a combination of radiation therapy (RT) and con...
Eligibility Criteria
Inclusion
- Pathologically confirmed locally advanced anal squamous cell carcinoma (including oligometastatic disease) with concurrent chemoradiation with standard Fluorouracil (5FU)/mitomycin regimen with curative intent
- Any cancer stage requiring a dose of 59.4 cGy
- 19 years of age or older
- Karnofsky Performance Status (KPS) ≥ 60%
- Hemoglobin ≥ 9.0 g/dl (a 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 SGOT and bilirubin ≤ 1.5 times upper limit of normal
- Negative pregnancy test for women of child-bearing potential within 48 hours prior to first dose of BMX-001
- Use of a medically effective means of birth control until 12 months following the last study treatment for women of childbearing potential and male participants
- Positron Emission Tomography (PET)/ Computed Tomography (CT)/pelvic magnetic resonance imaging (MRI) done within 8 weeks of trial initiation
Exclusion
- Breast-feeding
- Active infection requiring IV antibiotics within 7 days before enrollment
- Prior, unrelated malignancy requiring current active treatment, exception: 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 prostate cancer (Gleason 6 or less)
- Prior history of Acantholytic squamous cell carcinoma (ASCC)
- Prior history of pelvic radiotherapy for any other type of malignancy
- Known hypersensitivity to Fluorouracil (5FU) and/or mitomycin
- Current corticosteroid use unless dose is stable or decreasing at study enrollment (anti-inflammatory properties could interrupt oxidative stress)
- Inadequately controlled hypertension (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 (active) cardiovascular disease or cerebrovascular disease, (e.g., 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 from physical/neurological examination of central nervous system disease (e.g. seizures) unrelated to cancer, potentially interfering with protocol treatment unless adequately controlled by medication
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment
- 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
- History of additional risk factors for Torsades de Pointes (TdP) (e.g., congestive heart failure, hypokalemia, known family history of Long QT Syndrome)
Key Trial Info
Start Date :
November 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2029
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03386500
Start Date
November 28 2017
End Date
December 1 2029
Last Update
June 11 2025
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198