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New treatment option for Glioblastoma
Official title Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening
ClinicalTrials.gov ID: NCT06512311
What this study is testing
- What it's testing
- Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75
- ECOG performance status 0-2
- Newly diagnosed glioblastoma, IDH wildtype - according to the 2021 WHO classification of Tumors of the Central Nervous System
- MGMT promotor unmethylated per local investigator
- Tissue available for drug screening (successful PDC establishment from surgical material)
You likely can't join if
- Current participation in another therapeutic clinical trial
- Patients with a concurrent malignancy or malignancy within five years prior of study enrolment except for carcinoma in situ of the cervix...
- Pregnant or lactating women
- Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined...
- Known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection...
- Any of the following co-morbidities:
See the full eligibility criteria
- Age 18-75
- ECOG performance status 0-2
- Newly diagnosed glioblastoma, IDH wildtype - according to the 2021 WHO classification of Tumors of the Central Nervous System
- MGMT promotor unmethylated per local investigator
- Tissue available for drug screening (successful PDC establishment from surgical material)
- Scheduled for concomitant radio-chemotherapy with temozolomide
- Written informed consent
- Current participation in another therapeutic clinical trial
- Patients with a concurrent malignancy or malignancy within five years prior of study enrolment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma or stage I uterine cancer within the last 3 years
- Pregnant or lactating women
- Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antibody [HBsAg] test and a...
- Known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥350...
- Any of the following co-morbidities:
- Pre-existing severe peripheral neuropathy (\> CTCAE grade 2)
- Hepatic impairment (Bilirubin Level \>1.5x-3x ULN)
- Kidney dysfunction (CrCl \< 59 mL/min)
- Cardiac dysfunction with left ventricular ejection fraction \<60 %
- Any grade of interstitial lung disease
- Ongoing or previous history of rhabdomyolysis
- Acute pancreatitis
- QTcF ≥480 msec
- Diabetes mellitus with fasting glucose \> 250mg/dl or 13.9 mmol/L
- Participants who are unable or unwilling to comply with the requirements of the protocol as assessed by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, State of Vienna, Austria
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, State of Vienna, Austria. 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.