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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02507102
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Nativis, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Donna Morgan Murray, PhD
Principal Investigator Affiliation	Nativis, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Completed
Countries	Australia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme

Arms & Interventions

Arms

Experimental: Investigational Voyager Therapy

Investigational treatment with Voyager Therapy

Interventions

Device: - Voyager

Non-invasive RFE therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

St. Vincent's Hospital Melbourne, Melbourne, Victoria, Australia

Status

Address

St. Vincent's Hospital Melbourne

Melbourne, Victoria, 3065

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