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

Trial ID: NCT05380349

Interventional - Phase 1 - Recruiting

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.

Conditions

• Newly Diagnosed Glioblastoma

Interventions

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

Eligibility

Inclusion criteria

• 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)

Exclusion criteria

• 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

Sponsor

Swedish Medical Center

Source: ClinicalTrials.gov

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