Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma

Recruiting Phase 3 Interventional Study
Glioblastoma, IDH-wildtype MGMT-Methylated Glioblastoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Vastra Gotaland Region · Government
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About This Trial
Background: Glioblastoma (GBM) is notoriously difficult to treat, with current therapies often extending life by only a few months. The standard treatment involves surgery followed by radiation and chemotherapy with Temozolomide (TMZ). The efficacy of TMZ, however, is significantly enhanced when the tumor's o6-methylguanine-DNA-methyltransferase (MGMT) gene is methylated. Recent studies, such as t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Newly diagnosed glioblastoma/gliosarcoma, IDH wild type * Methylated MGMT promoter * World Health Organization performance status 0-2 * Age 18-70 Exclusion Criteria: * Previous malignancy within 3 y or malignancy treated non-curatively * Previous chemotherapy or radiotherapy…
Contacts

Asgeir S Jakola, MD, PhD

+46313429741

asgeir.jakola@vgregion.se

CONTACT

Annika Malmström, MD. PhD

annika.malmstrom@regionostergotland.se

CONTACT