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)
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Expanded Access
入排标准
- 接受健康志愿者
- 否
入选标准
- •unacceptable for single patient
排除标准
- •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)