NG101m Adjuvant Therapy in Glioblastoma Patients

Summary

The purpose of this clinical trial is to evaluate the addition of NG101m adjuvant therapy to standard of care treatment of glioblastoma multiforme. All subjects will receive NG101m capsules along with the standard treatment of temozolomide and radiation.

Interventions

• Intensity-modulated radiation therapy · RADIATION

  Intensity-modulated radiation therapy (IMRT) in daily fractions of 2.67 Gy given 5 days per week for 3 weeks, for a total of 40.05 Gy.

• Temozolomide · DRUG

  Oral temozolomide (75 mg/m2), given 5 days per week, for 3 weeks during radiotherapy. 1 month after the discontinuation of radiotherapy, oral temozolomide is restarted at 150 to 200 mg/m2 for 5 days during each 28-day cycle for 12 cycles.

• NG101m · DRUG

  Oral NG101m capsule continuously twice daily.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Male or female subjects ≥ 18 years of age
* Must be newly diagnosed with GBM
* Primary treatment must consist of a chemoradiation therapy (CRT) regimen
* Hemoglobin \> 9 g/dL
* White blood count 3,600 - 11,000/mm3
* Absolute neutrophil count (ANC) ≥ 1,500/mm3
* Absolute lymphocyte count (ALC) ≥ 1,000/mm3
* Platelet count 100,000/mm3
* BUN ≤ 1.5 times upper limit of normal
* Creatinine clearance rate \> 40 mL/min
* ALT ≤ 3 times upper limit of normal
* AST ≤ 3 times upper limit of normal
* Alkaline phosphatase ≤ 3 times upper limit of normal
* Total bilirubin ≤ 2.0 mg/dL
* Karnofsky Performance Status ≥ 70
* Must not be on any other alternative therapies
* Not pregnant

Exclusion Criteria:

* Known hypersensitivity to meloxicam, famotidine, and/or caffeine or any of their derivatives or components
* Known allergy to vitamin A, vitamin D3, and/or L-citrulline
* Pregnant women
* Breastfeeding women
* Corticosteroid therapy that cannot be tapered down to a dose of 1 - 2 mg/day of dexamethasone or its equivalent
* History of immunodeficiency diseases or autoimmune diseases
* History of peptic ulcer disease or gastrointestinal perforation

Sites (1)

• Yvonne Kew MD, PLLC, Houston, Texas