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New treatment option for Newly Diagnosed Glioblastoma
Official title Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma
ClinicalTrials.gov ID: NCT05380349
What this study is testing
What is combinations of up to 3 FDA approved drugs from a panel of compounds?
combinations of up to 3 FDA approved drugs from a panel of compounds is an investigational medicine, being studied as a potential treatment for newly diagnosed glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histological diagnosis of GBM (WHO grade 4)
- people ≥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
You likely can't join if
- 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
See the full eligibility criteria
- Histological diagnosis of GBM (WHO grade 4)
- people ≥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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.