NCT05380349 · Swedish Medical Center
Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma
What this study is about
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 the usual treatment radiation and TMZ.
View original scientific description
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.
Interventions
DRUG
combinations of up to 3 FDA approved drugs from a panel of compounds
personalized drug combinations
Primary outcome measures
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.
incidence of treatment-related AEs, laboratory abnormalities, and SAEs as assessed by CTCAE version 5.0
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 16, 2025 · Source of record for eligibility and locations