Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Early Phase 1

Recruiting

• Conditions: Newly Diagnosed Glioblastoma
• Interventions: Drug: combinations of up to 3 FDA approved drugs from a panel of compounds

• Registration Number: NCT05380349
• Lead Sponsor: Swedish Medical Center

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, 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.

Study Timeline

• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-18
• Study Start: 2024-04-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Personalized Combination Drug Therapy for Cancer Stem Cells	combinations of up to 3 FDA approved drugs from a panel of compounds	Administer combinations of up to 3 FDA approved drugs from a panel of compounds selected based on high throughput screening

Primary Outcome Measures

Name	Time	Method
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.	incidence of treatment-related AEs, laboratory abnormalities, and SAEs as assessed by CTCAE version 5.0

Secondary Outcome Measures

Name	Time	Method
Efficacy of CSC/HTS-based combination drug therapy	From inclusion in the study until date of death from any cause, assessed up to approximately 36 months	Median overall survival (OS)

Trial Locations

Locations (1)

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States