A Phase 1 Study of Combination Drug Therapy Based on Personalized Cancer Stem Cell (CSC) High-Throughput Drug Screening (HTS) With Standard of Care for Newly Diagnosed Glioblastoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- determine safety of CSC/HTS-based combination drug therapy
研究概览
简要总结
Proposed treatment of subjects with newly diagnosed glioblastoma with novel personalized drug regimens identified to be effective in vitro using cancer stem cells derived from their individual tumors, alongside standard of care radiation and TMZ.
详细描述
A panel of FDA approved drugs will be tested by high throughput screening, which is CLIA certified allowing for clinical decisions based on the results, to identify a combination of up to 3 drug candidates for treating individual patients. Lead candidates will be evaluated by pharmacists and a team of physicians, to confirm that prescribed drugs do not utilize pharmacological/ metabolic pathways that are known to increase the likelihood of toxicity, prior to initiating treatment. Investigational drug therapy, targeting CSCs, will be initiated alongside standard of care chemoradiation with TMZ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Histological diagnosis of GBM (WHO grade 4)
- •Subjects ≥18 years of age
- •Patients must have a life expectancy of >6 months
- •Patients must have a surgically accessible tumor with the intent for a gross or near total resection of the tumor mass (GBM, WHO grade 4)
- •Patients must have a KPS rating of ≥70
- •Patients should not have received any prior systemic anti-cancer therapy
- •Patients must be negative for HIV, Hepatitis B and C
- •Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
- •Hemoglobin (Hgb)> 8 g/dL
- •Absolute Neutrophil Count (ANC) > 1,000/mm3
- •Platelet count > 100,000/mm3
- •Creatinine < 2 mg/dL
- •Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 3x upper limit of normal (ULN)
排除标准
- •Metastatic disease
- •Diseases or conditions that obscure toxicity or dangerously alter drug metabolism
- •Serious intercurrent medical illness
- •Inadequately controlled hypertension
- •History of myocardial infarction or unstable angina within 6 months
- •History of stroke or transient ischemic attack within 6 months
研究组 & 干预措施
Personalized Combination Drug Therapy for Cancer Stem Cells
Administer combinations of up to 3 FDA approved drugs from a panel of compounds selected based on high throughput screening
干预措施: combinations of up to 3 FDA approved drugs from a panel of compounds (Drug)
结局指标
主要结局
determine safety of CSC/HTS-based combination drug therapy
时间窗: From date of first dose of investigational drug regimen until date of first documented progression or death from any cause, whichever came first, assessed up to 24 months.
incidence of treatment-related AEs, laboratory abnormalities, and SAEs as assessed by CTCAE version 5.0
次要结局
- Efficacy of CSC/HTS-based combination drug therapy(From inclusion in the study until date of death from any cause, assessed up to approximately 36 months)