A Multi-Center Pilot/Phase I and Phase II Clinical Trial of NG101m Adjuvant Therapy in Newly Diagnosed Glioblastoma Patients

Trial ID: NCT04373785

Interventional - Phase 1/2 - Not yet recruiting

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.

Conditions

• Glioblastoma Multiforme

Interventions

• Intensity-modulated radiation therapy
• Temozolomide
• NG101m

Eligibility

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

Sponsor

NeuGATE Theranostics

Source: ClinicalTrials.gov

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