A Multi-Center Pilot/Phase I and Phase II Clinical Trial of NG101m Adjuvant Therapy in Newly Diagnosed Glioblastoma Patients
NeuGATE Theranostics
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.
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 chemoradiotherap…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- RadiationIntensity-modulated radiation therapy
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.
- DrugTemozolomide
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.
- DrugNG101m
Oral NG101m capsule continuously twice daily.
Location
- Yvonne Kew MD, PLLCHouston, Texas