Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
NCT ID: NCT00054795
Last Updated: 2007-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
550 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Motexafin Gadolinium
Eligibility Criteria
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Inclusion Criteria
* KPS score of ≥70;
* Each patient must sign a study-specific Informed Consent form
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pharmacyclics LLC.
INDUSTRY
Locations
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Phoenix, Arizona, United States
Fort Smith, Arkansas, United States
Little Rock, Arkansas, United States
Berkeley, California, United States
Concord, California, United States
Greenbrae, California, United States
Los Angeles, California, United States
Montebello, California, United States
Sacramento, California, United States
Stanford, California, United States
Aurora, Colorado, United States
Hartford, Connecticut, United States
New Haven, Connecticut, United States
Chicago, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Washington D.C, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Camden, New Jersey, United States
Morristown, New Jersey, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Rochester, New York, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Laredo, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Charlottesville, Virginia, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Liverpool, New South Wales, Australia
St Leonards, New South Wales, Australia
Wollongong, New South Wales, Australia
Herston, Queensland, Australia
Woollongabba, Queensland, Australia
East Melbourne, Victoria, Australia
Footscray, Victoria, Australia
Geelong, Victoria, Australia
Heidelberg, Victoria, Australia
Linz, , Austria
Vienna, , Austria
Antwerp, , Belgium
Brussels, , Belgium
Haine-Saint-Paul, , Belgium
Leuven, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Caen, , France
Lille, , France
Lyon, , France
Montbéliard, , France
Nice, , France
Pierre-Bénite, , France
Rennes, , France
Saint-Herblain, , France
Vandœuvre-lès-Nancy, , France
Villejuif, , France
Aachen, , Germany
Berlin, , Germany
Essen, , Germany
Freiberg, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Herne, , Germany
Magdeburg, , Germany
München, , Germany
Gravenhage, , Netherlands
Heerlen, , Netherlands
Rotterdam, , Netherlands
Countries
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References
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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.
Carde 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.
Rosenthal 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.
Magda 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.
Miller 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.
Related Links
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National Brain Tumor Foundation
Other Identifiers
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PCYC-0211
Identifier Type: -
Identifier Source: org_study_id
NCT00066820
Identifier Type: -
Identifier Source: nct_alias