Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439849
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-07-12
First Post:
2024-05-28
Brief Title:
Single Patient Compassionate Use Expanded Access L-S-Gboxin Lyophilized Form of S-Gboxin for the Treatment of Diffuse Midline Glioma
Sponsor:
Petrov Andrey
Organization:
Petrov Andrey
Study Overview
Official Title:
Single Patient Compassionate Use Expanded Access L-S-Gboxin Lyophilized Form of S-Gboxin for the Treatment of Diffuse Midline Glioma H3 K27K28-altered TRIANGLE
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIANGLE
Brief Summary:
F 50yo 77kg DS confirmed 18 Nov 2022 Received treatment 11 courses of TMZ 240mg Radiotherapy 30 courses of 18Gr 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 patients participation in the Compassion Program TRIANGLE with L-S-Gboxi Lyophilisate - received
medical documentation will be available on clinicaltrialsgov within a month from the date of publication - patients consent to publish the medical history and examination results has been obtained
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 patients participation in the Compassion Program TRIANGLE with L-S-Gboxi Lyophilisate - received
medical documentation will be available on clinicaltrialsgov within a month from the date of publication - patients 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 mgkg
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 mgkg
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
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 mgkg
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 mgkg
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None