Status:
RECRUITING
Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma
Lead Sponsor:
Swedish Medical Center
Conditions:
Newly Diagnosed Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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,...
Detailed Description
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 candi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05380349
Start Date
April 19 2024
End Date
December 1 2027
Last Update
May 16 2025
Active Locations (1)
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1
Swedish Medical Center
Seattle, Washington, United States, 98122