Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer
NCT ID: NCT00083304
Last Updated: 2013-05-10
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
368 participants
INTERVENTIONAL
2004-02-29
2007-06-30
Brief Summary
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RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better.
This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place.
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Detailed Description
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All study patients will receive supplemental oxygen and whole brain radiation therapy (WBRT) (30 Gy, 3 Gy fractions) every weekday for 2 weeks. Half of the patients will be randomized (assigned) to receive RSR13 prior to WBRT, and will need to have a central catheter placed for treatment unless one is already in place. Patients who receive RSR13 will also need to continue to receive oxygen in the clinic until the amount of oxygen in their blood is near normal. This level has returned to near normal in most patients within 1 to 2 hours.
During treatment and follow-up visits, physical and neurological exam, KPS assessment, weight, height, and vital sign measurements, and about 2 teaspoons of blood may be required. Patients will need to return for follow-up visits 1 month after completion of treatment, 2 months later, and every 3 months thereafter until their doctor tells them otherwise.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Efaproxiral + WBRT + Supplemental Oxygen
Efaproxiral
75 mg/kg, administered over 30 minutes via a central venous access device (CVAD).
Administered 30 minutes prior to the start of whole brain radiation therapy (WBRT) on each WBRT treatment day for 10 days.
Whole Brain Radiation Therapy (WBRT)
3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.
Supplemental Oxygen
4 L/minute by nasal cannula.
Administered at least 35 minutes prior to WBRT, during WBRT and until 15 minutes after completion of WBRT on all WBRT treatment days.
WBRT + Supplemental Oxygen
Whole Brain Radiation Therapy (WBRT)
3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.
Supplemental Oxygen
4 L/minute by nasal cannula.
Administered at least 35 minutes prior to WBRT, during WBRT and until 15 minutes after completion of WBRT on all WBRT treatment days.
Interventions
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Efaproxiral
75 mg/kg, administered over 30 minutes via a central venous access device (CVAD).
Administered 30 minutes prior to the start of whole brain radiation therapy (WBRT) on each WBRT treatment day for 10 days.
Whole Brain Radiation Therapy (WBRT)
3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.
Supplemental Oxygen
4 L/minute by nasal cannula.
Administered at least 35 minutes prior to WBRT, during WBRT and until 15 minutes after completion of WBRT on all WBRT treatment days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Minimum KPS of 70
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Spectrum Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Allos Therapeutics, Inc.
Principal Investigators
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John Suh, MD
Role: STUDY_CHAIR
The Cleveland Clinic
Locations
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Virginia G. Piper Cancer Center, Arizona Oncology Services
Phoenix, Arizona, United States
Arizona Cancer Center, University of Arizona
Tucson, Arizona, United States
The University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
University of California at Los Angeles
Los Angeles, California, United States
Radiological Associates of Sacramento
Sacramento, California, United States
UCSF - Comprehensive Cancer Center
San Francisco, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Boca Raton Community Hospital
Boca Raton, Florida, United States
University of Miami Medical
Miami, Florida, United States
University of South Florida - H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Maryland Hematology Oncology
Baltimore, Maryland, United States
Franklin Square Hospital Center
Baltimore, Maryland, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dent Neurologic Institute
Amherst, New York, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Eastchester Center for Cancer Care
The Bronx, New York, United States
University of North Carolina Breast Center
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati Division of Hematology-Oncology
Cincinnati, Ohio, United States
Cleveland Clinic Hospital
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Texas Oncology
Dallas, Texas, United States
Texas Oncology
Fort Worth, Texas, United States
Virginia Mason Cancer Center
Seattle, Washington, United States
Wenatchee Valley Clinic
Wenatchee, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Instituto Medico Especializado Alexander Fleming
Buenos Aires, Cuidad de Buenos Aires, Argentina
Instituto de Oncologia A. Roffo
Buenos Aires, , Argentina
Hospital Espanol
Buenos Aires, , Argentina
Instituto Privado de Radioterapia y Oncologia
Córdoba, , Argentina
Centro de Terapia Radiante Cumbres (CAICI)
Rosario, , Argentina
LKH-Universitatsklinikum Graz
Graz, , Austria
Medical University Innsbruck
Innsbruck, , Austria
Hospital Sao Lucas PUC
Teófilo, Fortaleza Ceara, Brazil
Fundação Pio XII - Hospital do Câncer de Barretos
Barretos, São Paulo, Brazil
Hospital Erasto Gaertner
Curitiba, , Brazil
Velindre Hospital
Porto Alegre, , Brazil
Hospital Santa Rita da Irmandade da Santa Casa
Porto Alegre, , Brazil
Instituto Brasileiro de Controle do Cancer
São Paulo, , Brazil
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Center
Edmonton, Alberta, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
CHUM - Campus Notre Dame
Montreal, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Hotel-Dieu de Quebec du CHUQ
Québec, Quebec, Canada
Centre Hospitalier Universitarie de Service de Radio-Oncologie
Sherbrooke, Quebec, Canada
Cilnica Santa Maria
Providencia, Santiago de Chile, Chile
Clinical Hospital Osijek
Osijek, , Croatia
CHU Zagreb University School of Medicine
Zagreb, , Croatia
University Hospital for Tumors
Zagreb, , Croatia
Centre Georges François Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Léon Bérard
Lyon, , France
Hopital de Montbeliard
Montbéliard, , France
Centre Antioned Lacasagne
Nice, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Poitiers
Poitiers, , France
Clinique Armoricaine de
Saint-Brieuc, , France
Centre Rene Huguenin
Saint-Cloud, , France
Institut Gustave Roussy
Villejuif, , France
Hygeia Diagnostic and Therapeutic Center of Athens
Athens, , Greece
University of Debrecen
Debrecen, Hajdú-Bihar, Hungary
University of Szeged
Szeged, , Hungary
Azienda Ospedaliera Maggiore della Carita
Novara, , Italy
Ospedale S Chiara, University of Pisa
Pisa, , Italy
Kaunas Medical University Hospital
Kaunas, , Lithuania
Institute of Oncology, Vilnius University
Vilnius, , Lithuania
Hospital Edgardo Rebagliati Martins (ESSALUD)
Lima, , Peru
Radiooncologia, Radiation Oncology Center
Lima, , Peru
Instituto de Enfermedades Neoplasicas (INEN)
Lima, , Peru
Instituto Catalan de Oncologia (ICO)
Barcelona, , Spain
Ciutat Sanitari de Vall d'Hebron
Barcelona, , Spain
Hospital Ramon Y Cajal
Madrid, , Spain
Clinica Universitaria de Navarra
Pamplona, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
Velindre Hospital
Whitchurch, Cardiff, United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Beatson Oncolgy Center
Glasgow, , United Kingdom
Countries
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Other Identifiers
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RT-016
Identifier Type: -
Identifier Source: org_study_id
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