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

July 15, 2024 updated by: Petrov, Andrey

Single Patient Compassionate Use / Expanded Access L-S-Gboxin (Lyophilized Form of S-Gboxin) for the Treatment of Diffuse Midline Glioma, H3 K27/K28-altered (TRIANGLE)

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)

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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 Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Petrov, Andrey

Publications and helpful links

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Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21DN24S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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