Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
Randomized Phase III Trial of Xcytrin® (Motexafin Gadolinium) Injection for the Treatment of Brain Metastases in Patients With Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy
1 other identifier
interventional
550
7 countries
90
Brief Summary
The primary purpose of the study is to determine if patients with brain metastases from non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation therapy retain their neurologic function and ability to think for a longer time compared to patients treated with whole brain radiation therapy alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2003
CompletedFirst Posted
Study publicly available on registry
February 13, 2003
CompletedMay 8, 2007
May 1, 2007
February 10, 2003
May 4, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Adults (≥18 years old) with radiologically proven parenchymal brain metastases from histologically confirmed non-small cell lung cancer;
- KPS score of ≥70;
- Each patient must sign a study-specific Informed Consent form
You may not qualify if:
- Liver metastases;
- Extracranial metastases in two or more organs;
- Known leptomeningeal metastases or subarachnoid spread of tumor;
- Prior whole brain radiation;
- Plan to use radiosurgery or radiation boost after completion of WBRT;
- Planned chemotherapy during study treatment (prior and subsequent chemotherapy is allowed);
- Prior total resection of a single brain metastasis;
- Laboratory values as follows:
- LDH \> 1.3 x upper limit of normal (ULN); ANC \< 1500 /mm³; Platelets \< 50,000 /mm³; Creatinine \> 2.0 mg/dL; AST or ALT \> 2 x ULN; Total bilirubin \> 2 x ULN;
- Women who are pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (92)
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Phoenix, Arizona, United States
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Fort Smith, Arkansas, United States
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Little Rock, Arkansas, United States
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Berkeley, California, United States
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Concord, California, United States
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Greenbrae, California, United States
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Los Angeles, California, United States
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Montebello, California, United States
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Sacramento, California, United States
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Stanford, California, United States
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Aurora, Colorado, United States
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Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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Chicago, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Washington D.C, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Camden, New Jersey, United States
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Morristown, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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Rochester, New York, United States
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Akron, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Laredo, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Charlottesville, Virginia, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Liverpool, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Herston, Queensland, Australia
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Woollongabba, Queensland, Australia
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East Melbourne, Victoria, Australia
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Footscray, Victoria, Australia
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Geelong, Victoria, Australia
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Heidelberg, Victoria, Australia
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Linz, Austria
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Vienna, Austria
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Antwerp, Belgium
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Brussels, Belgium
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Haine-Saint-Paul, Belgium
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Leuven, Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Caen, France
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Lille, France
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Lyon, France
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Montbéliard, France
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Nice, France
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Pierre-Bénite, France
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Rennes, France
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Saint-Herblain, France
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Vandœuvre-lès-Nancy, France
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Villejuif, France
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Aachen, Germany
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Berlin, Germany
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Essen, Germany
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Freiberg, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Herne, Germany
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Magdeburg, Germany
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München, Germany
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Gravenhage, Netherlands
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Heerlen, Netherlands
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Rotterdam, Netherlands
Related Publications (5)
Mehta MP, Shapiro WR, Glantz MJ, Patchell RA, Weitzner MA, Meyers CA, Schultz CJ, Roa WH, Leibenhaut M, Ford J, Curran W, Phan S, Smith JA, Miller RA, Renschler MF. Lead-in phase to randomized trial of motexafin gadolinium and whole-brain radiation for patients with brain metastases: centralized assessment of magnetic resonance imaging, neurocognitive, and neurologic end points. J Clin Oncol. 2002 Aug 15;20(16):3445-53. doi: 10.1200/JCO.2002.07.500.
PMID: 12177105BACKGROUNDCarde P, Timmerman R, Mehta MP, Koprowski CD, Ford J, Tishler RB, Miles D, Miller RA, Renschler MF. Multicenter phase Ib/II trial of the radiation enhancer motexafin gadolinium in patients with brain metastases. J Clin Oncol. 2001 Apr 1;19(7):2074-83. doi: 10.1200/JCO.2001.19.7.2074.
PMID: 11283141BACKGROUNDRosenthal DI, Nurenberg P, Becerra CR, Frenkel EP, Carbone DP, Lum BL, Miller R, Engel J, Young S, Miles D, Renschler MF. A phase I single-dose trial of gadolinium texaphyrin (Gd-Tex), a tumor selective radiation sensitizer detectable by magnetic resonance imaging. Clin Cancer Res. 1999 Apr;5(4):739-45.
PMID: 10213207BACKGROUNDMagda D, Lepp C, Gerasimchuk N, Lee I, Sessler JL, Lin A, Biaglow JE, Miller RA. Redox cycling by motexafin gadolinium enhances cellular response to ionizing radiation by forming reactive oxygen species. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):1025-36. doi: 10.1016/s0360-3016(01)01810-7.
PMID: 11704327BACKGROUNDMiller RA, Woodburn K, Fan Q, Renschler MF, Sessler JL, Koutcher JA. In vivo animal studies with gadolinium (III) texaphyrin as a radiation enhancer. Int J Radiat Oncol Biol Phys. 1999 Nov 1;45(4):981-9. doi: 10.1016/s0360-3016(99)00274-6.
PMID: 10571206BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 10, 2003
First Posted
February 13, 2003
Last Updated
May 8, 2007
Record last verified: 2007-05