human stem cell derived neurons

Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 (BMX-HGG)

Summary

This phase II study will evaluate the safety and efficacy of BMX-001 in combination with standard of care radiation therapy and temozolomide (TMZ), in treating patients with newly diagnosed high-grade glioma (grades III-IV), including glioblastoma and anaplastic astrocytoma. 

BMX-001 is a class of compound called a "redox-active metalloporphyrin," and is administered via subcutaneous injection. This drug was designed to mimic an enzyme with antioxidant, anti-inflammatory, and potential chemoprotective activities. BMX-001 may protect normal tissues from the inflammatory side-effects of radiation and chemotherapy while at the same time acting as an antioxidant that may prevent tumor growth. Therefore this study will evaluate whether the addition of BMX-001 to radiation therapy and TMZ improves overall survival and cognition in patients with newly diagnosed high-grade glioma. 

In this Phase II clinical trial, eligible participants in this study will be randomized to the following treatment groups:

  • Experimental Group: BMX-001 + Radiation + TMZ
  • Active Comparator: Radiation + TMZ 

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Inclusion Criteria
  1. Subjects must have histologically confirmed diagnosis of World Health Organization (WHO) grade III or IV malignant glioma
  2. Subjects must be planning to start standard of care radiation therapy and chemotherapy
  3. Subjects must be within 12 weeks of last major neurosurgical procedure for the high-grade glioma (craniotomy, open biopsy, or stereotactic biopsy)
  4. Subjects must have had a definitive resection with residual radiographic contrast enhancement on post-resection CT or MRI of less than or equal to 2 cm in any two perpendicular planes on any images
  5. Age: 18 years and older
  6. Karnofsky Performance Status (KPS) ≥ 70%
  7. Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,500 cells/µl, platelets ≥ 125,000 cells/µl
  8. Serum creatinine ≤ 1.5 mg/dl, serum glutamate oxaloacetate transaminase (SGOT) and bilirubin ≤ 1.5 times upper limit of normal
  9. Signed informed consent approved by the Institutional Review Board
  10. If sexually active, patients must agree to use appropriate contraceptive measures for the duration of the study and for 12 months afterwards as stated in the informed consent
  11. Stable and/or decreasing dose of corticosteroids for greater than or equal to 7 days.

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Exclusion Criteria
  1. Pregnancy or breast-feeding
  2. Active infection requiring IV antibiotics 7 days before enrollment
  3. Signs of wound-healing problems or infection at the craniotomy/biopsy site.
  4. Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
  5. Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
  6. Prior treatment with radiotherapy or chemotherapy for a brain tumor, irrespective of the grade of the tumor
  7. Evidence of > grade 1 CNS hemorrhage on baseline MRI on CT scan
  8. Systemic treatment with inducers or strong inhibitors of cytochrome P450 within four days before enrollment or planned treatment during the time period of the study.
  9. Metal in the body (except dental fillings) e.g., pacemaker, infusion pump, metal aneurysm clip, metal prosthesis, joint, rod or plate.
  10. Severe allergy to contrast agent.
     

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Investigator(s)

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