Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Newly Diagnosed Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05380349
• Other study ID #: 161581
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 19, 2024
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Swedish Medical Center
• Contact: Charles S Cobbs, M.D.
• Phone: 206-320-2300
• Email: charles.cobbs[@]swedish.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Newly Diagnosed Glioblastoma

Intervention

Drug:
• combinations of up to 3 FDA approved drugs from a panel of compounds
personalized drug combinations

Locations

Country	Name	City	State
United States	Swedish Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Efficacy of CSC/HTS-based combination drug therapy	Response assessment per Response Assessment in Neuro-Oncology (RANO) criteria	From inclusion in the study up to approximately 36 months
Secondary	Efficacy of CSC/HTS-based combination drug therapy	Progression-free survival (PFS)	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
Secondary	Efficacy of CSC/HTS-based combination drug therapy	Median overall survival (OS)	From inclusion in the study until date of death from any cause, assessed up to approximately 36 months