Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат combinations of up to 3 FDA approved drugs from a panel of compounds
  personalized drug combinations

Первичные конечные точки

• determine safety of CSC/HTS-based combination drug therapy [Срок оценки: 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.]

Вторичные конечные точки (3)

• Efficacy of CSC/HTS-based combination drug therapy [Срок оценки: From inclusion in the study up to approximately 36 months]
• Efficacy of CSC/HTS-based combination drug therapy [Срок оценки: From inclusion in the study until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 36 months]
• Efficacy of CSC/HTS-based combination drug therapy [Срок оценки: From inclusion in the study until date of death from any cause, assessed up to approximately 36 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Swedish Medical Center — Seattle

Идентификаторы

NCT: NCT05380349 · 161581

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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