Clinical Trial 23777

• Overview

  Study Title:

  A Randomized, Masked, Placebo Controlled, Phase II Trial of Concurrent Chemoradiation with BMX-001 in Patients with Head and Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation

  Summary:

  This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.

  Objective:

  Primary Objective * To compare the incidence of severe oral mucositis (SOM) between BMX-001 and placebo, defined as >= Grade 3 per WHO criteria from the start of radiation through 4 weeks after completion of study treatment, with additional assessments at 6, 8 and 12 weeks after completion of study treatment. Secondary Objectives * To compare the duration of SOM in the BMX-001 arm vs. placebo arm. * To assess the difference between arms in the OMWQ-HN change score from baseline to 4 weeks after the end of chemoradiation. * To describe the incidence and severity of xerostomia and radiation dermatitis, as measured by CTCAE v5.0, in both arms. * To compare the duration of radiation dermatitis in the BMX-001 arm vs. placebo arm. * To describe toxicity, as measured by CTCAE v5.0 and PRO-CTCAE, in both arms.

• Treatments

  Therapies:

  Chemotherapy (NOS); Metalloporphyrins; Radiotherapy

  Medications:

  BMX-001/Placebo (); Radiotherapy (); cisplatin ()

• Inclusion Criteria

  Inclusion Criteria:
  • Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.
  • At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving >= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving >= 50 Gy must be documented by the enrolling physician and will be reviewed centrally to confirm eligibility.
  • Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.
  • P16 and/or human papillomavirus (HPV) status (via polymerase chain reaction [PCR] or in situ hybridization [ISH]) must be documented for patients with oropharynx cancer.
  • No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.
  • Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.
  • Age >= 18.
  • Zubrod performance status of 0-2.
  • Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3.
  • Platelets >= 100,000 cells/mm^3.
  • Hemoglobin >= 9.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable).
  • Adequate renal function defined as creatinine clearance (CrCL) > 50 mL/min by the Cockcroft-Gault formula.
  • Total bilirubin => Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) => No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa/level 4 neck.
  • No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.
  • No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.
  • No current treatment of adjuvant post-operative (op) chemoradiation.
  • No systemic treatment with inducers or strong inhibitors of cytochrome P450 => No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low risk prostate cancer.
  • No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.
  • Additional criteria may apply.

• Exclusion Criteria

  Exclusion Criteria:
  • Not meeting all of the inclusion criteria.

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