Spots Global Cancer Trial Database for A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma

Study Description

Brief Summary: A study designed to assess the safety of MTX110 in patients suffering with recurrent glioblastoma. MTX110 will be administered directly to the site of the tumour via a catheter which is inserted during a surgical procedure at the beginning of the study.

Detailed Description: A two cohort, ascending dose study of intra-tumoral MTX110 in patients with recurrent glioblastoma. With the aim to assess the safety and also the recommended phase 2 dose of MTX110. The patient will undergo a surgical procedure to insert a programmable pump and catheter system to allow administration of MTX110 directly to the tumour using Convection Enhanced Delivery (CED). Cohort A patients will receive one of three potential dose levels of MTX110 as a weekly infusion in order to establish recommended phase 2 dose. This will be based on an accelerated dose titration/3+3 design. Cohort B patients will follow the 3+3 study design with the starting concentration established in Cohort A. They too will receive MTX110 as a weekly infusion and may undergo catheter repositioning and continued treatment following progression.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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