A Multi-Center Pilot/Phase I and Phase II Clinical Trial of NG101m Adjuvant Therapy in Newly Diagnosed Glioblastoma Patients
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-emergent adverse events and serious adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NG101m and standard treatment
Concomittant therapy:
Radiation therapy, oral temozolomide, and oral NG101m
Adjuvant therapy:
Oral temozolomide and oral NG101m
干预措施: Intensity-modulated radiation therapy (Radiation)
NG101m and standard treatment
Concomittant therapy:
Radiation therapy, oral temozolomide, and oral NG101m
Adjuvant therapy:
Oral temozolomide and oral NG101m
干预措施: Temozolomide (Drug)
NG101m and standard treatment
Concomittant therapy:
Radiation therapy, oral temozolomide, and oral NG101m
Adjuvant therapy:
Oral temozolomide and oral NG101m
干预措施: NG101m (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events and serious adverse events
时间窗: 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.
时间窗: 24 months
Efficacy of NG101m adjuvant therapy will be assessed by measuring 2-year overall survival rate.
次要结局
- Progression-free survival (PFS)(24 months)
- Response assessment in neuro-oncology (RANO) criteria(24 months)