Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Early Phase 1RecruitingNCT05380349

Swedish Medical Center10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Newly Diagnosed Glioblastoma

Interventions

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

personalized drug combinations

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Swedish Medical Center

Seattle, Washington, United States

RECRUITING

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

Efficacy of CSC/HTS-based combination drug therapy

Response assessment per Response Assessment in Neuro-Oncology (RANO) criteria

Time frame: From inclusion in the study up to approximately 36 months

Efficacy of CSC/HTS-based combination drug therapy

Progression-free survival (PFS)

Time frame: 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

Efficacy of CSC/HTS-based combination drug therapy

Median overall survival (OS)

Time frame: From inclusion in the study until date of death from any cause, assessed up to approximately 36 months

Central Contacts

Charles S Cobbs, M.D.

CONTACT

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

Parvinder Hothi, Ph.D.

CONTACT

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

Data from ClinicalTrials.gov

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