Back to resultsStudy of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
Primary Purpose
Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Metastases, Neoplasm
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Motexafin Gadolinium
Sponsored by
About this trial
This is an interventional treatment trial for Brain Neoplasms focused on measuring Brain Neoplasms/radiotherapy, Neoplasms/complications/prevention & control,, Neuropsychological Tests,, Metalloporphyrins/therapeutic use,, Combined Modality Therapy,, Drug therapy,, Quality of Life,, Cranial Irradiation,, Radiotherapy/Targeted,, Prospective Studies,, Neoplasm Recurrence/Local,, Treatment Outcome, Brain metastases, Brain Neoplasms/secondary, Non-small cell lung cancer
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00054795
Brief Title
Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Pharmacyclics LLC.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Metastases, Neoplasm
Keywords
Brain Neoplasms/radiotherapy, Neoplasms/complications/prevention & control,, Neuropsychological Tests,, Metalloporphyrins/therapeutic use,, Combined Modality Therapy,, Drug therapy,, Quality of Life,, Cranial Irradiation,, Radiotherapy/Targeted,, Prospective Studies,, Neoplasm Recurrence/Local,, Treatment Outcome, Brain metastases, Brain Neoplasms/secondary, Non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
550 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Motexafin Gadolinium
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
City
Phoenix
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Arizona
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United States
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Fort Smith
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Little Rock
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Berkeley
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Concord
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Greenbrae
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Los Angeles
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Montebello
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Sacramento
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Stanford
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Aurora
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Colorado
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Hartford
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New Haven
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Chicago
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Fort Wayne
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Indianapolis
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Camden
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Morristown
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Albuquerque
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New York
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Rochester
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Akron
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Cleveland
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Columbus
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Hershey
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Philadelphia
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Knoxville
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Houston
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Laredo
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San Antonio
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Tyler
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Charlottesville
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Madison
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Milwaukee
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Liverpool
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Australia
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St. Leonards
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Australia
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Wollongong
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New South Wales
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Australia
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Herston
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Queensland
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Australia
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Woollongabba
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Queensland
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Australia
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East Melbourne
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Victoria
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Australia
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Footscray
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Victoria
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Australia
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Geelong
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Victoria
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Australia
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Heidelberg
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Victoria
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Australia
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Linz
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Austria
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Wien
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Austria
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Antwerpen
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Belgium
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Bruxelles
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Belgium
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Haine-Saint-Paul
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Belgium
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Leuven
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Belgium
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Calgary
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Canada
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Edmonton
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Canada
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Halifax
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Hamilton
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Kingston
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Ontario
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London
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Ontario
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Ottawa
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Toronto
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Montreal
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Quebec City
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Sherbrooke
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Caen
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France
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Lille
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France
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Lyon
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France
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Montbeliard
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France
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Nice
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France
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Pierre Benite
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France
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Rennes
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France
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Saint Herblain
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France
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Vandoeuvre Les Nancy
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France
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Villejuif
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France
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Aachen
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Germany
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Berlin
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Germany
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Essen
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Germany
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Freiberg
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Herne
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Germany
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Magdeburg
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Germany
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Munchen
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Germany
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Gravenhage
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Netherlands
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Heerlen
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Netherlands
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Rotterdam
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Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
12177105
Citation
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.
Results Reference
background
PubMed Identifier
11283141
Citation
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.
Results Reference
background
PubMed Identifier
10213207
Citation
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.
Results Reference
background
PubMed Identifier
11704327
Citation
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.
Results Reference
background
PubMed Identifier
10571206
Citation
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.
Results Reference
background
Links:
URL
http://www.braintumor.org
Description
National Brain Tumor Foundation
Learn more about this trial
Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
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