Nativis Voyager for Newly Diagnosed GBM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-10

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02296580

Glioblastoma Multiforme

COMPLETED NA

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

NCT02507102

Glioblastoma Multiforme

COMPLETED NA

Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma

NCT00782756

Brain Cancer Malignant Glioma

COMPLETED PHASE2

Bevacizumab, Temozolomide, and External Beam Radiation Therapy as First-Line Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

NCT01013285

Brain and Central Nervous System Tumors

COMPLETED PHASE2

An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

NCT02667587

Brain Neoplasms

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioblastoma Multiforme

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Nativis Voyager combined with standard radiotherapy and temozolomide

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nativis Voyager

Nativis Voyager combined with SOC Radiotherapy and temozolomide

Group Type EXPERIMENTAL

Nativis Voyager

Intervention Type DEVICE

Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nativis Voyager

Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No