Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Last updated: May 13, 2025
Sponsor: Swedish Medical Center
Overall Status: Active - Recruiting

Phase

1

Condition

Astrocytoma

Gliomas

Treatment

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

Clinical Study ID

NCT05380349
161581
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 neartotal 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 thefollowing 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 AlanineAminotransferase (ALT) < 3x upper limit of normal (ULN)

Exclusion

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

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: combinations of up to 3 FDA approved drugs from a panel of compounds
Phase: 1
Study Start date:
April 19, 2024
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Active - Recruiting

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