Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART) - Full Text View

Sponsor:	Pharmacyclics
Information provided by:	Pharmacyclics
ClinicalTrials.gov Identifier:	NCT00054795

Purpose

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.

Condition	Intervention	Phase
Brain Neoplasms Carcinoma, Non-Small-Cell Lung Metastases, Neoplasm	Drug: Motexafin Gadolinium	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Lung Cancer

Drug Information available for: Motexafin gadolinium Motexafin

U.S. FDA Resources

Further study details as provided by Pharmacyclics:

Estimated Enrollment:

550

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054795

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Locations

United States, Arizona

Phoenix, Arizona, United States
United States, Arkansas

Little Rock, Arkansas, United States

Fort Smith, Arkansas, United States
United States, California

Berkeley, California, United States

Greenbrae, California, United States

Sacramento, California, United States

Los Angeles, California, United States

Stanford, California, United States

Montebello, California, United States

Concord, California, United States
United States, Colorado

Aurora, Colorado, United States
United States, Connecticut

New Haven, Connecticut, United States

Hartford, Connecticut, United States
United States, Illinois

Chicago, Illinois, United States
United States, Indiana

Indianapolis, Indiana, United States

Fort Wayne, Indiana, United States
United States, Louisiana

Shreveport, Louisiana, United States
United States, Maryland

Baltimore, Maryland, United States

Washington D.C, Maryland, United States
United States, Massachusetts

Boston, Massachusetts, United States
United States, Michigan

Grand Rapids, Michigan, United States

Detroit, Michigan, United States
United States, Minnesota

Minneapolis, Minnesota, United States
United States, Missouri

St. Louis, Missouri, United States
United States, Nebraska

Omaha, Nebraska, United States
United States, New Jersey

Morristown, New Jersey, United States

Camden, New Jersey, United States
United States, New Mexico

Albuquerque, New Mexico, United States
United States, New York

Rochester, New York, United States

New York, New York, United States
United States, Ohio

Akron, Ohio, United States

Columbus, Ohio, United States

Cleveland, Ohio, United States
United States, Pennsylvania

Philadelphia, Pennsylvania, United States

Hershey, Pennsylvania, United States
United States, Tennessee

Knoxville, Tennessee, United States

Nashville, Tennessee, United States
United States, Texas

Laredo, Texas, United States

Houston, Texas, United States

Tyler, Texas, United States

San Antonio, Texas, United States
United States, Virginia

Charlottesville, Virginia, United States
United States, Wisconsin

Madison, Wisconsin, United States

Milwaukee, Wisconsin, United States
Australia, New South Wales

Liverpool, New South Wales, Australia

St. Leonards, New South Wales, Australia

Wollongong, New South Wales, Australia
Australia, Queensland

Woollongabba, Queensland, Australia

Herston, Queensland, Australia
Australia, Victoria

Heidelberg, Victoria, Australia

Geelong, Victoria, Australia

East Melbourne, Victoria, Australia

Footscray, Victoria, Australia
Austria

Wien, Austria

Linz, Austria
Belgium

Antwerpen, Belgium

Haine-Saint-Paul, Belgium

Bruxelles, Belgium

Leuven, Belgium
Canada, Alberta

Edmonton, Alberta, Canada

Calgary, Alberta, Canada
Canada, Nova Scotia

Halifax, Nova Scotia, Canada
Canada, Ontario

London, Ontario, Canada

Toronto, Ontario, Canada

Ottawa, Ontario, Canada

Kingston, Ontario, Canada

Hamilton, Ontario, Canada
Canada, Quebec

Montreal, Quebec, Canada

Sherbrooke, Quebec, Canada

Quebec City, Quebec, Canada
France

Lyon, France

Saint Herblain, France

Montbeliard, France

Lille, France

Rennes, France

Pierre Benite, France

Caen, France

Villejuif, France

Nice, France

Vandoeuvre Les Nancy, France
Germany

Hamburg, Germany

Heidelberg, Germany

Aachen, Germany

Freiberg, Germany

Berlin, Germany

Munchen, Germany

Herne, Germany

Magdeburg, Germany

Essen, Germany
Netherlands

Rotterdam, Netherlands

Gravenhage, Netherlands

Heerlen, Netherlands

Sponsors and Collaborators

Pharmacyclics

More Information

Additional Information:

National Brain Tumor Foundation This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

Study ID Numbers:	PCYC-0211
Study First Received:	February 10, 2003
Last Updated:	May 4, 2007
ClinicalTrials.gov Identifier:	NCT00054795 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pharmacyclics:

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

Additional relevant MeSH terms:

Thoracic Neoplasms
Antineoplastic Agents
Physiological Effects of Drugs
Central Nervous System Neoplasms
Brain Diseases
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasm Metastasis
Dermatologic Agents
Nervous System Neoplasms

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Central Nervous System Diseases
Motexafin gadolinium
Pharmacologic Actions
Carcinoma
Brain Neoplasms
Neoplasms
Photosensitizing Agents
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009