NCT05380349EARLY_PHASE1Recruiting

Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Swedish Medical Center

Start Date

4/19/2024

Completion Date

12/1/2027

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, alongside standard of care radiation and TMZ.

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 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

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

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Conditions

Newly Diagnosed Glioblastoma

Locations

Swedish Medical Center

Seattle, Washington 98122

United States