Clinical trial · Interventional
Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening
Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening: Advanced Brain Tumor TheRApy Clinical Trial (ATTRACT)
NCT06512311CI-TRIAL-00108221ATTRACTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CBMed Drug Screening Plattform | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PDC-based drug screening
- description
- 120 patients will be included in the intervention group and will receive PDC-based drug screening. The molecular tumor board will formulate a personalized treatment recommendation by incorporating the individual characteristics of the patients including age, co-morbidities, co-medication, and performance status in addition to the results of the PDC-based drug screening.
- interventionNames
- Diagnostic Test: CBMed Drug Screening Plattform
- type
- NO_INTERVENTION
- label
- Standard group
- description
- 120 patients will be included in the standard group and will not receive PDC-based drug screening. In line, no personalized treatment approach will be formulated by the molecular tumor board and patients will all receive the recommendation for standard treatment including temozolomide maintenance therapy for 6 cycles.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion 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 Exclusion Criteria: * 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 positive anti-hepatitis B core antibody \[HBcAb\] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for anti-HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. * 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 cells/mm3 , no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen). If an HIV infection meets the above criteria, monitoring of viral RNA load and CD4+ count is recommended. * 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.
References
Publications (1)
- DERIVEDBerghoff AS, Mair MJ, Spiro Z, Abdel Malak C, El-Heliebi A, Eckert F, Furtner J, Konig F, Leibetseder A, Nowosielski M, Oberndorfer S, Prietl B, Pichler J, Pieber TR, Spiegl-Kreinecker S, Urbanic Purkart T, Wohrer A, Widhalm G, Preusser M; ATTRACT study group. Personalized targeted glioblastoma therapies by ex vivo drug screening: Study protocol of the Advanced brain Tumor TheRApy Clinical Trial (ATTRACT). Neurooncol Adv. 2025 Mar 7;7(1):vdaf056. doi: 10.1093/noajnl/vdaf056. eCollection 2025 Jan-Dec. PMID 40351832