RecruitingEarly Phase 1NCT05380349

Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

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

Sponsor

Swedish Medical Center

Enrollment

10 participants

Start Date

Apr 19, 2024

Study Type

INTERVENTIONAL

Conditions

Newly Diagnosed Glioblastoma

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

Min Age: 18 Years

Inclusion Criteria13

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 Criteria6

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

Interventions

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

personalized drug combinations

Locations(1)

Swedish Medical Center

Seattle, Washington, United States

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NCT05380349

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