跳至主要内容
临床试验/CTRI/2025/03/082390
CTRI/2025/03/082390尚未招募3 期

Pilot Study for intra-tumoral administration of L- 2,4- Diamino-N-Butyric Acid Dihydrochloride (DAB) and Prazosin in 10 recurrent glioblastoma patients

St Johns Medical College Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年3月25日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
10
试验地点
1
主要终点
RANO(Response Assessment in Neuro-Oncology ) criteria of non recurrence 6 months post treatment

研究概览

简要总结

Elimination of High-grade Gliomas Through Induced Cytolysis, Elucidated by Two Patient Cases

CHRISTOS PANOTOPOULOS, GEORGE ATHANASIOU, STAVROS STAVROPOULOS, NICK BOUTOS, SHAILESH RAO, GEORGE PANAYOTOU, NEELAM K. VENKATARAMANA and GUNNAR RONQUIST

Anticancer Research January 2025, 45 (1) 201-207; DOI: https://doi.org/10.21873/anticanres.17405

Glioblastoma multiforme (GBM) is the most common and aggressive form of primary malignant tumors in the central nervous system of adults. In practice, all patients with GBM experience relapse, and treatment options become limited following first-line therapy. We previously reported a new, successful treatment approach for a GBM patient, implemented in direct conjunction with surgical intervention. Case Report: Here, we present an additional case demonstrating the success of this protocol, along with an overview of its underlying rationale and mechanisms. Following maximal safe tumor resection, our protocol involves the placement of two catheters in the tumor excision bed, connected to drug infusion pumps for continuous administration. The tumor’s excision beds are irrigated for 90-120 hours with a slightly alkaline Tris-buffered solution containing L-2,4 diaminobutyric acid, an unnatural amino acid, and Prazosin, a proapoptotic drug widely used as an antihypertensive. Both patients demonstrated marked clinical improvement. Recent contrast-enhanced magnetic resonance imaging revealed no evidence of malignancy, with Case 1 remaining disease-free for seven years and Case 2 for two years of follow-up. Conclusion: This innovative approach not only enhances local drug delivery but also minimizes systemic side effects, addressing a critical challenge in GBM treatment. These cases highlight the potential of this protocol as an adjunct to standard therapies, offering a promising option for managing inoperable or recurrent GBM.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • histopathologically confirmed glioblastoma with MR evidence of neurosurgically significant recurrence
  • age between 18 and 75 years
  • any other existing inclusion criteria of the Neurosurgery Department of the hospital.

排除标准

  • absence of informed consent
  • age outside the range for inclusion
  • extension of the lesion across the midline to the contralateral hemisphere
  • any other existing exclusion criteria of the Neurosurgery Department of the hospital.

结局指标

主要结局

RANO(Response Assessment in Neuro-Oncology ) criteria of non recurrence 6 months post treatment

时间窗: 6 months post treatment

次要结局

  • Time to recurrence.

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shailesh A V Rao

St. Johns Medical College Hospital

研究点 (1)

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