NG101m Adjuvant Therapy in Glioblastoma Patients

Sponsor: NeuGATE Theranostics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04373785

Patient View

This trial assesses NG101m as an adjuvant to standard glioblastoma treatment. Participants, newly diagnosed and ≥18, receive NG101m with temozolomide and radiation. Eligibility includes specific blood counts and organ function. Interventions involve IMRT, temozolomide, and continuous NG101m dosing, aiming to improve 2-year overall survival rates.

Patient Parameters

Program Overview

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.

Description

Glioblastoma multiforme (GBM) is the most lethal form of malignant brain cancer, with about 12,000 new cases diagnosed each in the the United States. The current standard treatment consists of maximal, safe resection, followed by radiation therapy of 60 Gray (Gy) with concomitant oral temozolomide (TMZ) for 6 weeks, then continue with six cycles of high-dose temozolomide. The median survival rate for newly diagnosed GBM patients is 14.6 months with a 2-year overall survival (OS) rate of 27.2%. This clinical trial evaluates the 2-year OS of oral NG101m as an adjuvant therapy to chemoradiotherapy in newly diagnosed GBM subjects.

Eligibility Criteria

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

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