A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma

• Status: Not yet recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

Summary

A study designed to assess the safety of MTX-110 alone and in combination with lomustine for patients suffering with recurrent glioblastoma. MTX-110 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Midatech Ltd
• Treatments: Lomustine

Criteria

Inclusion Criteria:

• Recurrent glioblastoma

• Patients must be healthy enough to tolerate surgery and general anesthesia;

• Estimated life expectancy of greater than 3 months.

Exclusion Criteria:

• Patients scheduled to undergo or are undergoing re-irradiation for the recurrent tumour

• Patients with a history of glioblastoma treatment with nitrosoureas

• Patients who cannot undergo MRI

• Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks, or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)] prior to starting the study drug

• Patients may not have received treatment with tumor treating fields ≤ 1 week prior to starting the study drug;

• Patients may not be less than 12 weeks from completion of radiation therapy for the primary tumor

• Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord; radiological evidence of active (growing) disease (active multifocal disease); extensive subependymal disease (tumor touching subependymal space is allowed); tumor crossing the midline or leptomeningeal disease;

• Posterior fossa location of the tumor, regardless of its morphology;

• Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin (treatment with tamoxifen or aromatase inhibitors or other hormonal therapy that may be indicated in prevention of prior cancer disease recurrence, are not considered current active treatment);