Glioblastoma Multiforme
Conditions
Brief 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.
Detailed 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.
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.
Sponsors
NeuGATE Theranostics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Radiation: Radiotherapy Drug: Temozolomide Drug: NG101m
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-emergent adverse events and serious adverse events | 1 month | Safety and tolerability of NG101m as adjuvant therapy to chemoradiation therapy |
| Efficacy of NG101m adjuvant chemoradiation therapy assessed by measuring 2-year overall survival rate. | 24 months | Efficacy of NG101m adjuvant therapy will be assessed by measuring 2-year overall survival rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 24 months | Assess the duration of PFS |
| Response assessment in neuro-oncology (RANO) criteria | 24 months | Radiological response to adjuvant NG101m therapy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Identify and quantify immune/effector cells | 24 months | Cytokines measurement |
Countries
United States
Contacts
Primary ContactThien Tran, PharmD
Outcome results
None listed