A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/1/2019 |
| Start Date: | December 2014 |
| End Date: | December 2019 |
| Contact: | Donna Morgan Murray, PhD |
| Email: | dmorganmurray@nativis.com |
| Phone: | 206-708-2288 |
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.
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.
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.
We found this trial at
13
sites
Boca Raton, Florida 33486
Principal Investigator: Sajeel Chowdhary, MD
Phone: 561-955-4800
Click here to add this to my saved trials
2450 E. River Road
Tucson, Arizona 85718
Tucson, Arizona 85718
520-320-2147
Principal Investigator: Michael Badruddoja, MD
Click here to add this to my saved trials
1301 West 38th Street
Austin, Texas 78705
Austin, Texas 78705
Principal Investigator: Brian D Vaillant, MD
Phone: 512-324-7000
Click here to add this to my saved trials
Birmingham, Alabama 35294
Principal Investigator: Burt Nabors, MD
Phone: 205-934-1842
Click here to add this to my saved trials
Encinitas, California 92024
Principal Investigator: Edward McClay, MD
Phone: 760-452-3909
Click here to add this to my saved trials
Fairfield, Connecticut 06824
Principal Investigator: Jeffrey Gross, MD
Phone: 203-333-1151
Click here to add this to my saved trials
Kansas City, Kansas 66303
Principal Investigator: Michael Salacz, MD
Phone: 913-588-5520
Click here to add this to my saved trials
41 Victoria Parade
Melbourne, 3065
Melbourne, 3065
Principal Investigator: Anthony Dowling, MD
Phone: 03 9231 3551
Click here to add this to my saved trials
Portland, Oregon 97225
Principal Investigator: Ricky Chen, MD
Phone: 503-202-7934
Click here to add this to my saved trials
2200 Santa Monica Boulevard
Santa Monica, California 90404
Santa Monica, California 90404
Principal Investigator: Garni Barkhoudarian, MD
Phone: 310-582-7097
Click here to add this to my saved trials
Seattle, Washington 98101
Principal Investigator: Lynne Taylor, MD
Phone: 206-287-5629
Click here to add this to my saved trials
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
Click here to add this to my saved trials
Temple, Texas 76508
Principal Investigator: Ekokobe Fonkem, DO
Phone: 254-724-5939
Click here to add this to my saved trials