A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)

Not Applicable

Completed

• Conditions: Glioblastoma Multiforme
• Interventions: Device: Nativis Voyager RFE Therapy

• Registration Number: NCT02296580
• Lead Sponsor: Nativis, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-20
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nativis Voyager RFE Therapy	Nativis Voyager RFE Therapy	Subjects will be treated with Nativis Voyager therapy until tumor progression.

Primary Outcome Measures

Name	Time	Method
Number of any adverse events associated with the investigational therapy.	Through one month following investigational treatment	Safety Assessment as assessed by adverse events

Secondary Outcome Measures

Name	Time	Method
Clinical Utility: OS	18 months	Overall Survival
Clinical Utility: PFS	Six months	Progression Free Survival as assessed by RANO

Trial Locations

Locations (13)

John Wayne Cancer Institute @ Providecne St. Johns Health Center; 🇺🇸 Santa Monica, California, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

Associated Neurologists of Southern CT, P.C.; 🇺🇸 Fairfield, Connecticut, United States

St Vincent's Hospital Melbourne; 🇦🇺 Melbourne, Australia

Boca Raton Regional Hospital; 🇺🇸 Boca Raton, Florida, United States

Cancer Care Collaborative; 🇺🇸 Austin, Texas, United States

Providence Brain & Spine Institute; 🇺🇸 Portland, Oregon, United States

Virginia Mason Hospital & Medical Center; 🇺🇸 Seattle, Washington, United States

University of Kansas Medical Center (KUMC); 🇺🇸 Kansas City, Kansas, United States

Center for Neurosciences; 🇺🇸 Tucson, Arizona, United States

University of Alabama at Birmingham (UAB); 🇺🇸 Birmingham, Alabama, United States

cCARE - California Cancer Associates for Research & Excellence; 🇺🇸 Encinitas, California, United States

Baylor Scott & White Health; 🇺🇸 Temple, Texas, United States