Clinical trial NCT02296580: A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
Official title: A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma Multiforme
Lead sponsor: Nativis, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This feasibility study will assess the effects of the Nativis Voyager therapy in patients with first or second recurrence of GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to 32 subjects with Voyager plus lomustine with or without bevacizumab. Safety and clinical utility will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Subject has histologically confirmed diagnosis of GBM.
* Subject has failed or intolerant to radiotherapy.
* Subjects has failed or intolerant to temozolomide therapy.
* Subject has progressive disease with at least one measureable lesion on MRI.
* Subject is at least 18 years of age.
* Subject has a KPS ≥ 60.
* Subject has adequate organ and marrow function.

Exclusion Criteria:

* Subject has received bevacizumab (Avastin).
* Subjecting has any condition, including compromised pulmonary function, that would preclude the use of lomustine.
* Subject is currently being treated with other investigational agents.
* Subject has received other investigational therapy within the last 28 days.
* Subject has received surgery within the last four weeks.
* Subject is within 12 weeks of completion of radiation.
* Subject has an active implantable or other electromagnetic device.
* Subject has a metal implant, including a programmable shunt, 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 course of the study.

Primary outcomes:
measure: Number of any adverse events associated with the investigational therapy.
timeFrame: Through one month following investigational treatment
Secondary outcomes:
measure: Clinical Utility: PFS
timeFrame: Six months
measure: Clinical Utility: OS
timeFrame: 18 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB)
state: Alabama
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Encinitas
country: United States
facility: cCARE - California Cancer Associates for Research & Excellence
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute @ Providecne St. Johns Health Center
state: California
city: Fairfield
country: United States
facility: Associated Neurologists of Southern CT, P.C.
state: Connecticut
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center (KUMC)
state: Kansas
city: Portland
country: United States
facility: Providence Brain & Spine Institute
state: Oregon
city: Austin
country: United States
facility: Cancer Care Collaborative
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Health
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Hospital & Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne
Study officials:
affiliation: Nativis, Inc.
name: Donna Morgan Murray, PhD
role: STUDY_DIRECTOR
References: