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)

Petrov, Andrey

Status and phase: Suspended; Phase 1

Conditions: Glioblastoma Multiforme; Giant Cell Glioblastoma; Gliosarcoma; GBM; Diffuse Midline Glioma, H3 K27M-Mutant

Treatments: Biological: S-Gboxin

Study type: Interventional

Funder types: Other

Identifiers

NCT06806228

STM 0125-2G

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Patients will be offered 4 courses of Gboxin during (or without) standard treatment.

Experimental group

Description:

Patients will be offered 4 courses of S-Gboxin during standard treatment. Each course (18 days) consists of twice daily intake of S-Gboxin for 14 days and four days of rest. Each dose of S-Gboxin is packed in a gelatin capsule with a bandage and applied markings.

Treatment:

Biological: S-Gboxin