Clinical trial · Interventional
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
NCT02296580CI-TRIAL-00063637completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nativis Voyager RFE Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nativis Voyager RFE Therapy
- description
- Subjects will be treated with Nativis Voyager therapy until tumor progression.
- interventionNames
- Device: Nativis Voyager RFE Therapy
Primary outcomes (1)
- measure
- Number of any adverse events associated with the investigational therapy.
- timeFrame
- Through one month following investigational treatment
- description
- Safety Assessment as assessed by adverse events
Secondary outcomes (2)
- measure
- Clinical Utility: PFS
- timeFrame
- Six months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBarkhoudarian G, Badruddoja M, Blondin N, Chowdhary S, Cobbs C, Duic JP, Flores JP, Fonkem E, McClay E, Nabors LB, Salacz M, Taylor L, Vaillant B, Gill J, Kesari S. An expanded safety/feasibility study of the EMulate Therapeutics Voyager System in patients with recurrent glioblastoma. CNS Oncol. 2023 Sep 1;12(3):CNS102. doi: 10.2217/cns-2022-0016. Epub 2023 Jul 18. PMID 37462385