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Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

NCT05380349 · Swedish Medical Center
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
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
About this study
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
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
Study design
Enrollment target: 10 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-04-19
Estimated completion: 2027-12
Last updated: 2025-05-16
Interventions
Drug: combinations of up to 3 FDA approved drugs from a panel of compounds
Primary outcomes
  • determine safety of CSC/HTS-based combination drug therapy (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.)
Sponsor
Swedish Medical Center · other
Contacts & investigators
ContactCharles S Cobbs, M.D. · contact · charles.cobbs@swedish.org · 206-320-2300
ContactParvinder Hothi, Ph.D. · contact · parvinder.hothi@swedish.org · 206-320-3145
InvestigatorCharles S Cobbs · principal_investigator, Ivy Center for Advanced Brain Tumor Treatment
All locations (1)
Swedish Medical CenterRecruiting
Seattle, Washington, United States
Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma · TrialPath