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
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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2450 E. River Road
Tucson, Arizona 85718
Tucson, Arizona 85718
520-320-2147
Principal Investigator: Michael Badruddoja, MD
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1301 West 38th Street
Austin, Texas 78705
Austin, Texas 78705
Principal Investigator: Brian D Vaillant, MD
Phone: 512-324-7000
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Birmingham, Alabama 35294
Principal Investigator: Burt Nabors, MD
Phone: 205-934-1842
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Boca Raton, Florida 33486
Principal Investigator: Sajeel Chowdhary, MD
Phone: 561-955-4800
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Encinitas, California 92024
Principal Investigator: Edward McClay, MD
Phone: 760-452-3909
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Fairfield, Connecticut 06824
Principal Investigator: Jeffrey Gross, MD
Phone: 203-333-1151
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Kansas City, Kansas 66303
Principal Investigator: Michael Salacz, MD
Phone: 913-588-5520
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41 Victoria Parade
Melbourne, 3065
Melbourne, 3065
Principal Investigator: Anthony Dowling, MD
Phone: 03 9231 3551
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Portland, Oregon 97225
Principal Investigator: Ricky Chen, MD
Phone: 503-202-7934
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2200 Santa Monica Boulevard
Santa Monica, California 90404
Santa Monica, California 90404
Principal Investigator: Garni Barkhoudarian, MD
Phone: 310-582-7097
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Seattle, Washington 98101
Principal Investigator: Lynne Taylor, MD
Phone: 206-287-5629
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Temple, Texas 76508
Principal Investigator: Ekokobe Fonkem, DO
Phone: 254-724-5939
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