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

Not Applicable

Completed

• Conditions: Glioblastoma Multiforme
• Interventions: Device: Voyager

• Registration Number: NCT02507102
• Lead Sponsor: Nativis, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-23
• Study Start: 2015-08
• Primary Completion: 2017-12
• Status Verified: 2018-03
• Study Completion: 2018-03-26
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational Voyager Therapy	Voyager	Investigational treatment with Voyager Therapy

Primary Outcome Measures

Name	Time	Method
Tumor Response	2 months	Tumor imaging response (RANO) at two months of therapy.
Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System	6 months

Secondary Outcome Measures

Name	Time	Method
Progression free survival	6 months
Overall survival at six months compared with historical response	6 months

Trial Locations

Locations (1)

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