NCT05380349

Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Swedish Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Newly Diagnosed Glioblastoma

Interventions

Type	Name	Description
DRUG	combinations of up to 3 FDA approved drugs from a panel of compounds	personalized drug combinations

Timeline

• Start date: 2024-04-19
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2022-05-18
• Last updated: 2025-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study