Vortioxetine for Newly Diagnosed Glioblastoma

ConditionGlioblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Zurich

About this trial

There is a very urgent need to improve on the currently limited treatment options for patients with glioblastoma. Despite extensive knowledge on the molecular pathogenesis of glioblastoma obtained through genomic, transcriptional and proteomic profiling, targeted therapy efforts have not yielded major advances, likely because of interindividual and intraindividual tumor heterogeneity and redundant oncogenic pathway activation.

Accordingly, there is a strong rationale to approach the challenge of glioblastoma from a different angle, e.g., by ex vivo drug sensitivity profiling which is agnostic to the molecular profile of a tumor. This approach that we have termed "pharmacoscopy", has previously been explored in liquid cancers and probably led to improved patient outcomes. Using pharmacoscopy, the antidepressant drug, vortioxetine, has been identified as a lead candidate for further exploration in patients with glioblastoma. Vortioxetine also demonstrated synergistic anti-glioma activity in combination with temozolomide or lomustine.

The ReVoGlio trial aims at demonstrating that vortioxetine, a drug selected based on ex vivo drug profiling (pharmacoscopy), is of benefit for patients with newly diagnosed glioblastoma.

Eligibility criteria

Qualifiers

Male or female, age ≥18 years

Patients with histologically confirmed newly diagnosed glioblastoma per CNS WHO 2021 classification

O6-methylguanine DNA methyltransferase (MGMT) promotor methylation status known or tissue available for testing

Karnofsky performance status (KPS) ≥ 70%

Disqualifiers

Absolute neutrophil count (ANC) < 1.5 x 10.9/L; platelets < 100 x 10.9/L

Hemoglobin (Hb) < 9.0 g/dl. Blood marrow values must be measured independently of transfusion.

Chronically impaired renal function as indicated by creatinine clearance < 50 mL/min or serum creatinine > 1.5 upper limit of normal (ULN).

Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN) 9. Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol, in the opinion of the investigator.

Trial design

Treatments tested in this trial

  • Vortioxetine

Treatment groups

78 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Zurich

Lead sponsor

University Hospital, Zürich

Collaborator

University Hospital, Basel, Switzerland

Collaborator

Cantonal Hospital of St. Gallen

Collaborator

Kantonsspital Aarau

Collaborator

Cantonal Hospital of Lucerne, Switzerland

Collaborator