Safety Study of BMX-001 in Patients with Newly Diagnosed Anal Cancer

Sponsor: University of Nebraska

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03386500

Provider View

This clinical trial is testing the safety and effectiveness of BMX-001, a new drug, when used with standard radiation and chemotherapy in patients with newly diagnosed anal cancer. The study aims to find the best dose and see if BMX-001 can reduce side effects on normal tissues like the rectum, bladder, and skin.

Patient Parameters

Program Overview

This study is exploring whether BMX-001, a new drug, can be safely combined with standard radiation therapy and chemotherapy (5-fluorouracil and mitomycin) in patients with newly diagnosed anal cancer. The main goals are to find the highest safe dose of BMX-001 and to see if it can help reduce severe side effects on normal tissues during treatment.

Description

This clinical trial is testing a new drug called BMX-001 in combination with standard treatments for anal cancer. The study is divided into two phases. In Phase 1, researchers will determine the safest dose of BMX-001 when given with radiation and chemotherapy. In Phase 2, they will examine if BMX-001 can reduce severe side effects on normal tissues like the rectum, bladder, and skin.

Previous studies have shown that BMX-001 can be given safely at certain doses without causing serious side effects. In this trial, patients will receive BMX-001 through an injection under the skin before starting radiation therapy. Blood samples will be taken at various times to study how the drug is processed in the body.

Patients will be monitored for side effects during and after treatment, with follow-up visits to check on their health and any changes in symptoms. The study aims to improve treatment outcomes for patients with anal cancer by reducing the side effects of standard therapies.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with locally advanced anal squamous cell carcinoma, including cases with limited spread, and receiving standard chemoradiation with 5FU/Mitomycin.
  • Cancer stage requires a radiation dose of 59.4 cGy.
  • Aged 19 years or older.
  • Good overall health with a performance status of 60% or higher.
  • Adequate blood counts and organ function as determined by specific tests.
  • Signed informed consent to participate in the study.
  • Negative pregnancy test for women of childbearing potential before starting BMX-001.
  • Agree to use effective birth control during and for 12 months after treatment.
  • Recent PET/CT or pelvic MRI scan within 8 weeks before starting the trial.

Exclusion Criteria

  • Currently breastfeeding.
  • Active infection requiring IV antibiotics within 7 days before joining the study.
  • History of other cancers needing active treatment, except for certain skin cancers or cancers with a 5-year disease-free period.
  • Previous anal cancer or pelvic radiation for other cancers.
  • Allergic to 5FU or mitomycin.
  • Uncontrolled high blood pressure or history of low blood pressure and autonomic dysfunction.
  • Allergic to BMX-001.
  • Significant heart or blood vessel disease, recent heart attack, or stroke.
  • History of seizures or other central nervous system diseases unless controlled by medication.
  • Long QT syndrome or other heart rhythm issues.

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