Recruiting
Early Phase 1

Cancer Stem Cell

Sponsor:

Swedish Medical Center

Code:

NCT05380349

Conditions

Newly Diagnosed Glioblastoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Newly Diagnosed Glioblastoma

Study ID

NCT05380349

Start date

Apr 19, 2024

Status verified date

May, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

10 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Personalized Combination Drug Therapy for Cancer Stem Cells

Administer combinations of up to 3 FDA approved drugs from a panel of compounds selected based on high throughput screening

Interventions

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

personalized drug combinations

Primary outcome measure

  • determine safety of CSC/HTS-based combination drug therapy [ 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. ]

Central Contacts and Locations

Central contacts

Charles S Cobbs, M.D.

206-320-2300charles.cobbs@swedish.org

Parvinder Hothi, Ph.D.

206-320-3145parvinder.hothi@swedish.org

Locations

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122

Contacts

Nathan Hansen

206-320-3542nathan.hansen@swedish.org

More Information

Sponsor

Swedish Medical Center

Last update posted

May 16, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Swedish Medical Center on 2025-05-16.