Clinical trial NCT06806228: Phase I Pilot Study to Evaluate the Anti-glioblastoma Effect of S-Gboxin in Standard Treatment of Glioblastoma/Diffuse Midline Glioma and Response to Treatment (Regardless of Mutation Status)
Official title: Phase I Pilot Study to Evaluate the Anti-glioblastoma Effect of S-Gboxin in Standard Treatment of Glioblastoma/Diffuse Midline Glioma and Response to Treatment (Regardless of Mutation Status)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Glioblastoma Multiforme
Diffuse Midline Glioma, H3 K27M-Mutant
Gliosarcoma
Giant Cell Glioblastoma
GBM
Lead sponsor: Petrov, Andrey
Sponsor class: OTHER
Collaborators: name: Lytvin,Ruslan
First posted: 2025-02-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this pilot study is to evaluate the efficacy of adding S-Gboxin to standard RT/TMZ treatment protocols in patients with glioblastoma multiforme (GBM) or midline glioma (DMG), regardless of their mutation status

Detailed description: This is a pilot study to evaluate the efficacy of adding the mitochondrial oxidative phosphorylation inhibitor S-Gboxin (OXPHOS) to standard treatment for glioblastoma multiforme or glioma.

Subjects will start oral S-gboxin orally twice daily and will evaluate the patients and vital status if they tolerate this dose at 3, 7and 15 days after initiation.

Patients will undergo MRI scans before treatment and then at multiple time points during their participation in this Clinical Trial to monitor early tumor response to treatment ( MRI dates will be scheduled by the clinical trial coordinator)

Peripheral blood samples will be collected at baseline, days 1-7-15-28-36-72 to compare biological indicators of treatment response. In some cases, circulating tumor cells (CTCs) will be monitored by real-time qRT-PCR to correlate with clinical data.

Patients will also be assessed for the side effects they experience. Disease-free and overall survival outcomes will be recorded.

Patients will also have their depressive symptoms, quality of life, and neurocognitive function assessed at multiple time points during and after treatment.

After completion of the study, patients will be followed up at 3 months.

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of Glioblastoma according to RANO criteria by contrast-enhanced MRI or PET-CT (including diffuse midline glioma, gliosarcoma or giant cell glioblastoma), relapse or disease progression
* patient is able to understand and give consent to participate in the study
* Karnofsky performance score ≥ 60
* women of childbearing potential must have a negative pregnancy test result no later than 7 days before registration

Exclusion Criteria:

* pregnant
* known allergies
* active treatment on annotner clinical trial
* inability to complete with protocol or studio procedures.

Primary outcomes:
measure: Brain tumor metabolism as measured by PET and MRI
timeFrame: Up to 6 month
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 12 month
measure: Incidence of adverse events graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version (v)4.03
timeFrame: Up to 1 month after last dose of S-Gboxin
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Tbilisi Cancer Centre
city: Almaty
country: Kazakhstan
facility: Kazakh Institute of Oncology and Radiology
city: Kyiv
country: Ukraine
facility: National Cancer Institute
Study officials:
References: