Single Patient Compassionate Use / Expanded Access L-S-Gboxin (Lyophilized Form of S-Gboxin) for the Treatment of Diffuse Midline Glioma

• Conditions: DIPG Brain Tumor; Diffuse Brainstem Glioma; H3 K27M; H3 K28M; GBM

• Registration Number: NCT06439849
• Lead Sponsor: Petrov, Andrey

Brief Summary

F. 50y.o. 77kg, DS confirmed 18 Nov. 2022 Received treatment: 11 courses of TMZ (240mg) Radiotherapy 30 courses of 1.8Gr (total 54 Gr, TMZ 140 mg on RT). Bevacizumab intravenously -400 mg -0-14-28-42 (December-February 2023). Severe side effects. The attending physician discontinued bevacizumab after 4 courses. In remission for 11 months. According to the results of the MRI dated April 28, 2024, continued growth.

Neurological status is good. Reflexes are not impaired. To date, treatment options have been exhausted. Participation of the patient in Clinical Trials is impossible. As of April 2024, negative dynamics. The patient signed an informed consent agreement. Information on taking L-S-Gboxin (Lyophilisate) as part of a compassionate program - explained.

Written consent of the attending physician for the patient's participation in the Compassion Program (TRIANGLE) with L-S-Gboxi (Lyophilisate) - received.

(medical documentation will be available on clinicaltrials.gov within a month from the date of publication - patient's consent to publish the medical history and examination results has been obtained)

Detailed Description

TREATMENT PLAN

Оn days 1 to 3 of treatment, the patient will receive a sublingual form of the lyophilized form of L-S-Gboxin at a dose of 5 mg/kg.

If there is no toxicity, on days 4 to 14 the patient will receive a sublingual form of the lyophilized form of S-Gboxin at a dose of 10 mg/kg.

The first course of treatment is 14 days. On day 20, MRI + PET-CT monitoring is carried out to assess the dynamics of tumor growth. Based on the results of the examination plan, the attending physician and the main investigator make a decision on the continuation of treatment and the duration of the second course of therapy.

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-31
• Study First Posted: 2024-06-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

unacceptable for single patient

Exclusion Criteria

• unacceptable cardiotoxicity
• cerebrospinal fluid dissemination
• systemic infection or viral disease, other associated symptoms that may jeopardize the patient's safety (at the discretion of the treating physician)

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified