Glioblastoma Multiforme
Conditions
Brief summary
This feasibility study will assess the effects of the Nativis Voyager therapy in patients with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to eleven subjects over six months. Safety and clinical utility will be evaluated.
Interventions
DEVICEVoyager
Non-invasive RFE therapy
Sponsors
Nativis, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has histologically confirmed diagnosis of GBM. 2. Subject has failed or intolerant to radiotherapy. 3. Subjects has failed or intolerant to temozolomide therapy. 4. Subject has progressive disease with at least one measureable lesion on MRI or CT. 5. Subject is at least 18 years of age. 6. Subject has a KPS ≥ 60. 7. Subject has adequate organ and marrow function. 8. Subject has provided signed informed consent.
Exclusion criteria
1. Subject has life expectancy less than eight weeks 2. Subject has received other investigational therapy within the last 28 days. 3. Subject has received surgery within the last two weeks or not fully from prior surgery. 4. Subject has a clinically significant electrolyte abnormality. 5. Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device. 6. Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI. 7. Subject is known to be HIV positive. 8. Subject is pregnant, nursing or intends to become pregnant during the study period. 9. Subject is participating in other investigational research. 10. Subject has any condition that at the discretion of the investigator would preclude participation in the study. 11. Subject is unable or unwilling to comply with the protocol-required follow-up schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System | 6 months | — |
| Tumor Response | 2 months | Tumor imaging response (RANO) at two months of therapy. |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival at six months compared with historical response | 6 months |
| Progression free survival | 6 months |
Countries
Australia
Outcome results
None listed