NG101m Adjuvant Therapy in Glioblastoma Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Radiation: Intensity-modulated radiation therapy
* Drug: Temozolomide
* Drug: NG101m


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Radiation: Radiotherapy Drug: Temozolomide Drug: NG101m
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NG101m and standard treatment<br>Concomittant therapy: Radiation therapy, oral temozolomide, and oral NG101m Adjuvant therapy: Oral temozolomide and oral NG101m | Radiation: Intensity-modulated radiation therapy<br>* 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.<br>* Other names: radiation therapy;Drug: Temozolomide<br>* 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.<br>* Other names: Temodar;Drug: NG101m<br>* Oral NG101m capsule continuously twice daily.<br>* Other names: NG101m regimen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-emergent adverse events and serious adverse events | Safety and tolerability of NG101m as adjuvant therapy to chemoradiation therapy | 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Assess the duration of PFS | 24 months | 
| Response assessment in neuro-oncology (RANO) criteria | Radiological response to adjuvant NG101m therapy | 24 months | 
| Quality of Life (QoL) | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | 24 months |