Clinical trial NCT03276286: Nativis Voyager for Newly Diagnosed GBM
Official title: A Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma Multiforme
Lead sponsor: Nativis, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-08
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Nativis Voyager combined with standard radiotherapy and temozolomide
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Treatment-related Adverse Events (Safety)
timeFrame: Through study completion, average of 1 year
Secondary outcomes:
measure: Clinical Utility PFS
timeFrame: 6 months
measure: Clinical Utility OS
timeFrame: Through patient completion, expected average 8 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Encinitas
country: United States
facility: California Cancer Care Associates
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute @ Providence St Johns Health Center
state: California
city: Fairfield
country: United States
facility: Associated Neurologists of Southern CT, PC
state: Connecticut
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital
state: Florida
city: Austin
country: United States
facility: Cancer Care Collaborative
state: Texas
city: Temple
country: United States
facility: Baylor Scott and White Health
state: Texas
Study officials:
affiliation: Nativis, Inc.
name: Donna Morgan Murray, PhD
role: STUDY_CHAIR
References: