Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening

NCT ID: NCT06512311

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2031-12-31

Brief Summary

Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach.

Detailed Description

Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach. Patients will be randomized between the investigational group receiving in addition to standard histology analysis also the PDC-based drug screening and the standard group receiving only standard histology analysis. Outcome results will be compared in a randomized, interventional clinical performance study. The PDC-based drug screening will be performed only in accordance with the approved Performance Study Plan on subjects who have signed an informed consent form.

Conditions

Glioblastoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PDC-based drug screening

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.

Group Type: EXPERIMENTAL

CBMed Drug Screening Plattform

Intervention Type: DIAGNOSTIC_TEST

The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics.

Standard group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CBMed Drug Screening Plattform

The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Anna Berghoff

Assoc.-Prof. PD DDr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AKH Vienna, Department for Internal Medicine I, Oncology

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Anna Berghoff, MD

Role: primary

anna.berghoff@meduniwien.ac.at

+43140400 ext. 44450

Marika Rosner

Role: backup

marika.rosner@meduniwien.ac.at

+43140400 ext. 44450

References

Berghoff 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.

Reference Type: DERIVED

PMID: 40351832 (View on PubMed)

Other Identifiers

ATTRACT

Identifier Type: -

Identifier Source: org_study_id