Glioblastoma Multiforme
Conditions
Brief summary
This feasibility study will assess the effects of the Nativis Voyager therapy in patients with first or second recurrence of GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to 32 subjects with Voyager plus lomustine with or without bevacizumab. Safety and clinical utility will be evaluated.
Interventions
DEVICENativis Voyager RFE Therapy
Nativis Voyager Radiofrequency Energy 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
* Subject has histologically confirmed diagnosis of GBM. * Subject has failed or intolerant to radiotherapy. * Subjects has failed or intolerant to temozolomide therapy. * Subject has progressive disease with at least one measureable lesion on MRI. * Subject is at least 18 years of age. * Subject has a KPS ≥ 60. * Subject has adequate organ and marrow function.
Exclusion criteria
* Subject has received bevacizumab (Avastin). * Subjecting has any condition, including compromised pulmonary function, that would preclude the use of lomustine. * Subject is currently being treated with other investigational agents. * Subject has received other investigational therapy within the last 28 days. * Subject has received surgery within the last four weeks. * Subject is within 12 weeks of completion of radiation. * Subject has an active implantable or other electromagnetic device. * Subject has a metal implant, including a programmable shunt, in the head or neck that is incompatible with MRI. * Subject is known to be HIV positive. * Subject is pregnant, nursing or intends to become pregnant during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of any adverse events associated with the investigational therapy. | Through one month following investigational treatment | Safety Assessment as assessed by adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Utility: PFS | Six months | Progression Free Survival as assessed by RANO |
| Clinical Utility: OS | 18 months | Overall Survival |
Countries
Australia, United States
Outcome results
None listed