Study on the Effectiveness and Safety of Short and Long Course Radiation Therapy With or Without BMX-001

Program Overview

The purpose of this study is to determine if the investigational drug BMX-001, when combined with either short-course or long-course radiation therapy, can help treat patients with newly diagnosed rectal cancer. The study will evaluate how well these combinations work and how safe they are for patients.

Description

This study involves two groups of patients:

• Group 1: This group will start with a safety phase involving 6 patients who will receive long-course chemoradiotherapy (LCCRT) with the drug capecitabine. The safety of this treatment will be reviewed before moving to the next phase.

• Group 2: This group will begin with a randomized study of patients receiving short-course radiation therapy (SCRT).

Both groups will start enrolling patients at the same time. In Group 1, patients will receive LCCRT with capecitabine during the safety phase. In Group 2, patients will be part of a randomized study receiving SCRT.

Patients in the safety phase will receive BMX-001, starting with a loading dose followed by maintenance doses twice a week, along with either SCRT or LCCRT. After initial treatment, patients will receive additional chemotherapy cycles and then be assigned to either SCRT or LCCRT before randomization. Patients will be randomly assigned to receive BMX-001 or not. The study will measure skin, gastrointestinal, and urinary symptoms at various points.

Inclusion Criteria:

• Patients with locally advanced rectal cancer who will receive a full treatment plan aimed at curing the cancer.
• Cancer stage II to III that requires full treatment.
• Adults aged 18 or older (19 in Nebraska).
• Good overall health with specific performance status scores.
• Adequate blood counts and organ function as determined by specific tests.
• Signed informed consent before any study procedures.
• Negative pregnancy test for women who can have children.
• Agreement to use effective birth control during and after the study.
• Recent imaging tests done within 8 weeks of starting the trial.

Exclusion Criteria:

• Pregnant or breastfeeding women.
• Active infections requiring IV antibiotics recently.
• Other cancers requiring active treatment, except for certain types.
• Previous history of rectal cancer or pelvic radiation.
• Allergies to any study medications.
• Uncontrolled high blood pressure or heart conditions.
• Certain medications that could interfere with the study.
• Specific health conditions that could affect participation.

Note: The study is open to all genders and ethnic groups.

Eligibility Criteria