Status:
COMPLETED
Nativis Voyager for Newly Diagnosed GBM
Lead Sponsor:
Nativis, Inc.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03276286
Start Date
November 10 2017
End Date
May 31 2022
Last Update
February 2 2023
Active Locations (7)
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1
Center for Neurosciences
Tucson, Arizona, United States, 85718
2
California Cancer Care Associates
Encinitas, California, United States, 92024
3
John Wayne Cancer Institute @ Providence St Johns Health Center
Santa Monica, California, United States, 90404
4
Associated Neurologists of Southern CT, PC
Fairfield, Connecticut, United States, 06824