Status:
TERMINATED
A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma
Lead Sponsor:
Biodexa Pharmaceuticals
Conditions:
Recurrent Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 durin...
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...
Eligibility Criteria
Inclusion
- Recurrent glioblastoma.
- Patients must be healthy enough to tolerate surgery and general anesthesia.
- Estimated life expectancy of greater than 3 months.
Exclusion
- Patients scheduled to undergo or are undergoing re-irradiation for the recurrent tumour.
- Patients with a history of glioblastoma treatment with carmustine or Gliadel® wafers.
- 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; 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).
Key Trial Info
Start Date :
October 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT05324501
Start Date
October 19 2022
End Date
September 10 2024
Last Update
February 10 2025
Active Locations (2)
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1
Baptist MD Anderson
Jacksonville, Florida, United States, 32207
2
Duke University Hospital
Durham, North Carolina, United States, 27710