NCT05380349RecruitingEarly phase 1
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
Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 21 Apr 2022
- Start date
- 19 Apr 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Swedish Medical Center
- Diseases
- Glioblastoma
- NCT number
- NCT05380349
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 10
- From 19 Apr 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Swedish Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.