An Early Phase 1 interventional study of combinations of up to 3 FDA approved drugs from a panel of compounds in Newly Diagnosed Glioblastoma, sponsored by Swedish Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Swedish Medical Center · Early Phase 1, Interventional, and Treatment
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.
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 10 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Swedish Medical Center is the lead sponsor of 40 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
Exclusion Criteria:
Administer combinations of up to 3 FDA approved drugs from a panel of compounds selected based on high throughput screening
Drug: combinations of up to 3 FDA approved drugs from a panel of compounds
personalized drug combinations
determine safety of CSC/HTS-based combination drug therapy
incidence of treatment-related AEs, laboratory abnormalities, and SAEs as assessed by CTCAE version 5.0
Time frame: 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.
Efficacy of CSC/HTS-based combination drug therapy
Response assessment per Response Assessment in Neuro-Oncology (RANO) criteria
Time frame: From inclusion in the study up to approximately 36 months
Efficacy of CSC/HTS-based combination drug therapy
Progression-free survival (PFS)
Time frame: 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
Median overall survival (OS)
Time frame: From inclusion in the study until date of death from any cause, assessed up to approximately 36 months
Plan to share: No
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