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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
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.
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.
Oral NG101m capsule continuously twice daily.
Yvonne Kew MD, PLLC
Houston, Texas, United States
Number of participants with treatment-emergent adverse events and serious adverse events
Safety and tolerability of NG101m as adjuvant therapy to chemoradiation therapy
Time frame: 1 month
Efficacy of NG101m adjuvant chemoradiation therapy assessed by measuring 2-year overall survival rate.
Efficacy of NG101m adjuvant therapy will be assessed by measuring 2-year overall survival rate.
Time frame: 24 months
Progression-free survival (PFS)
Assess the duration of PFS
Time frame: 24 months
Response assessment in neuro-oncology (RANO) criteria
Radiological response to adjuvant NG101m therapy
Time frame: 24 months
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