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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507102
• Other study ID #: NAT-105
• Status: Completed
• Phase: N/A
• First received: July 22, 2015
• Last updated: March 28, 2018
• Start date: August 2015
• Est. completion date: March 26, 2018

Study information

• Verified date: March 2018
• Source: Nativis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 26, 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Device:
• Voyager
Non-invasive RFE therapy

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital Melbourne	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Nativis, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System		6 months
Primary	Tumor Response	Tumor imaging response (RANO) at two months of therapy.	2 months
Secondary	Overall survival at six months compared with historical response		6 months
Secondary	Progression free survival		6 months