MAGIC-G1: A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 MTX-110.
The patient will undergo a surgical procedure to insert a programmable pump and catheter system to allow administration of MTX-110 directly to the tumour. The patient will receive one of up to a potential three doses of MTX-110 either as monotherapy (cohort A) or combined with lomustine (cohort B). This will be based on an accelerated dose titration/3+3 design.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MTX-110 monotherapy
|
Drug: MTX110
Soluble panobinostat
Device: Programmable pump and catheter system
To allow Convection-Enhanced Delivery (CED)
|
| Experimental: MTX-110 combined with lomustine
|
Drug: MTX110
Soluble panobinostat
Device: Programmable pump and catheter system
To allow Convection-Enhanced Delivery (CED)
Drug: Lomustine
Chemotherapy agent
|
Outcome Measures
Primary Outcome Measures
- The frequency and nature of adverse events, serious adverse events and dose limiting toxicities (DLTs) [Safety of MTX110 administered by CED alone and in combination with lomustine] [Through study completion, an expected average of 16 weeks]
- To determine the recommended Phase 2 dose (RP2D) of MTX110 alone and in combination with lomustine [Through study completion, an expected average of 16 weeks]
Secondary Outcome Measures
- Overall survival [12 months]
- Progression-free survival [6 months]
- Best overall response rate [6 months]
Eligibility Criteria
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);
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Midatech Ltd
Investigators
- Study Director: Dmitry Zamoryakhin, Midatech Pharma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MTX110-102