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Nativis Voyager for Newly Diagnosed GBM

Study Purpose

This feasibility study will assess the effects of the Nativis Voyager therapy in patients newly diagnosed with GBM. The study will enroll and treat up to 32 subjects and will be combined with standard of care radiotherapy and temozolomide.

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:

  • - There is pathological evidence of GBM using World Health Organization (WHO) classification.
  • - Subject received maximal debulking surgery.
Patients may enroll in the study if received Gliadel wafers before entering the trial. Any additional treatments received prior to enrollment will be considered an exclusion.
  • - Subject must have at least one measurable lesion per RANO.
  • - Subject is at least 18 years of age.
  • - Subject has a Karnofsky Performance Scale (KPS) ≥ 60.
  • - Subject has life expectancy > 3 months.
  • - Subject has adequate organ and marrow function; see note 1.
  • - Subject able to start treatment at least 28 days from tumor resection surgery.
  • - Subject has provided signed informed consent.

Exclusion Criteria:

  • - Subject has progressive disease per RANO.
If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
  • - Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness) - Subject is currently being treated with Optune.
  • - Subject is currently being treated with other investigational agents.
  • - Subject has not sufficiently recovered from prior surgery in the opinion of the investigator.
  • - Subject has significant co-morbidities at baseline which would prevent radiotherapy and/or temozolomide treatment.
  • - Subject has history of hypersensitivity reaction to temozolomide or a history of hypersensitivity to dacarbazine (DTIC).
  • - Subject has a clinically significant electrolyte abnormality.
  • - Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device that is incompatible with MRI.
Subjects with programmable shunt are excluded from the study.
  • - Subject has a metal implant, including a stent, 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 study period.
  • - Subject is participating in other potentially confounding investigational research.
  • - Subject has any condition that at the discretion of the investigator would preclude participation in the study.
  • - 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.

 NCT03276286
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 United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Arms & Interventions

Arms

Experimental: Nativis Voyager

Nativis Voyager combined with SOC Radiotherapy and temozolomide

Interventions

Device: - Nativis Voyager

Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide

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.

Center for Neurosciences, Tucson, Arizona

Status

Address

Center for Neurosciences

Tucson, Arizona, 85718

California Cancer Care Associates, Encinitas, California

Status

Address

California Cancer Care Associates

Encinitas, California, 92024

Santa Monica, California

Status

Address

John Wayne Cancer Institute @ Providence St Johns Health Center

Santa Monica, California, 90404

Fairfield, Connecticut

Status

Address

Associated Neurologists of Southern CT, PC

Fairfield, Connecticut, 06824

Boca Raton Regional Hospital, Boca Raton, Florida

Status

Address

Boca Raton Regional Hospital

Boca Raton, Florida, 33486

Cancer Care Collaborative, Austin, Texas

Status

Address

Cancer Care Collaborative

Austin, Texas, 78705

Baylor Scott and White Health, Temple, Texas

Status

Address

Baylor Scott and White Health

Temple, Texas, 98101

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