Personalized drug screening for glioblastoma treatment
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
This study is testing if personalized combinations of FDA-approved drugs can improve treatment for people with newly diagnosed glioblastoma when used with standard therapy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Swedish Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05380349 on ClinicalTrials.gov |
What this trial studies
This study aims to treat patients with newly diagnosed glioblastoma by identifying effective personalized drug regimens through high-throughput screening of cancer stem cells derived from their tumors. A panel of FDA-approved drugs will be tested to find a combination of up to three candidates that can be used alongside standard chemoradiation therapy. The selected drug candidates will be evaluated for safety and efficacy by a team of pharmacists and physicians before treatment initiation. This approach seeks to enhance treatment outcomes by tailoring therapies to individual patient profiles.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a histological diagnosis of glioblastoma and a life expectancy of more than six months.
Not a fit: Patients with metastatic disease or those who have received prior systemic anti-cancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with glioblastoma.
How similar studies have performed: While personalized approaches to cancer treatment are gaining traction, this specific method of using high-throughput screening for glioblastoma is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seattle, Washington
- Swedish Medical Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Charles S Cobbs — Ivy Center for Advanced Brain Tumor Treatment
- Study coordinator: Charles S Cobbs, M.D.
- Email: charles.cobbs@swedish.org
- Phone: 206-320-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.