NG101m Adjuvant Therapy in Glioblastoma Patients
- Conditions
- Glioblastoma Multiforme
- Interventions
- Registration Number
- NCT04373785
- Lead Sponsor
- NeuGATE Theranostics
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 52
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NG101m and standard treatment Intensity-modulated radiation therapy Concomittant therapy: Radiation therapy, oral temozolomide, and oral NG101m Adjuvant therapy: Oral temozolomide and oral NG101m NG101m and standard treatment NG101m Concomittant therapy: Radiation therapy, oral temozolomide, and oral NG101m Adjuvant therapy: Oral temozolomide and oral NG101m NG101m and standard treatment Temozolomide Concomittant therapy: Radiation therapy, oral temozolomide, and oral NG101m Adjuvant therapy: Oral temozolomide and oral NG101m
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Quality of Life (QoL) 24 months European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Response assessment in neuro-oncology (RANO) criteria 24 months Radiological response to adjuvant NG101m therapy
Progression-free survival (PFS) 24 months Assess the duration of PFS
Trial Locations
- Locations (1)
Yvonne Kew MD, PLLC
🇺🇸Houston, Texas, United States