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Standard Whole Brain Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Women With Brain Metastases From Breast Cancer
This study has been completed.
First Received: May 18, 2004   Last Updated: November 2, 2007   History of Changes
Sponsor: Allos Therapeutics
Information provided by: Allos Therapeutics
ClinicalTrials.gov Identifier: NCT00083304
  Purpose

RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy.

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.


Condition Intervention Phase
Breast Cancer
Metastases
Procedure: Whole brain radiation therapy with supplemental oxygen
Drug: RSR13
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase 3, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Women With Brain Metastases From Breast Cancer

Resource links provided by NLM:


Further study details as provided by Allos Therapeutics:

Estimated Enrollment: 360
Study Start Date: February 2004
Study Completion Date: June 2007
Detailed Description:

The screening process will include documentation of the cancer, which which will require a brain scan and may include a liver scan. Other screening measurements will include a Karnofsky Performance Status (KPS) assessment, measurement of the amount of oxygen in the blood, using a non-invasive device most often placed on the finger, lung function tests that will require blowing into a machine, and an electrocardiogram (ECG). About 2 teaspoons, or 10 mL, of blood will be taken for specific laboratory tests, and a pregnancy test will be done on the blood of women of childbearing potential.

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.

  Eligibility

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

Inclusion Criteria:

  • Adult women with brain metastases from breast cancer
  • Minimum KPS of 70

Exclusion Criteria:

  • Previous treatment for brain metastases, including brain surgery and any form of radiation to the brain
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083304

  Hide Study Locations
Locations
United States, Arizona
Virginia G. Piper Cancer Center, Arizona Oncology Services
Phoenix, Arizona, United States, 85013
Arizona Cancer Center, University of Arizona
Tucson, Arizona, United States, 85724-5081
United States, Arkansas
The University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
University of California at Los Angeles
Los Angeles, California, United States, 90095
UCSF - Comprehensive Cancer Center
San Francisco, California, United States, 94115
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
Radiological Associates of Sacramento
Sacramento, California, United States, 95816
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Boca Raton Community Hospital
Boca Raton, Florida, United States, 33486
University of Miami Medical
Miami, Florida, United States, 33136
University of South Florida - H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Parkview Research Center
Ft. Wayne, Indiana, United States, 46805
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46204
United States, Iowa
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
Maryland Hematology Oncology
Baltimore, Maryland, United States, 21236
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Dent Neurologic Institute
Amherst, New York, United States, 14226
Eastchester Center for Cancer Care
Bronx, New York, United States, 10469
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
University of North Carolina Breast Center
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic Hospital
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
University of Cincinnati Division of Hematology-Oncology
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Texas Oncology
Fort Worth, Texas, United States, 76104
Texas Oncology
Dallas, Texas, United States, 75230
United States, Washington
Wenatchee Valley Clinic
Wenatchee, Washington, United States, 98801
Virginia Mason Cancer Center
Seattle, Washington, United States, 98101
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Canada, Alberta
Cross Cancer Center
Edmonton, Alberta, Canada, T6G 1Z2
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Canada, Quebec
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
CHUM - Campus Notre Dame
Montreal, Quebec, Canada, H2L 4M1
Hotel-Dieu de Quebec du CHUQ
Quebec City, Quebec, Canada, G1R 5C3
Centre Hospitalier Universitarie de Service de Radio-Oncologie
Sherbrooke, Quebec, Canada, J1H 5N4
McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Allos Therapeutics
Investigators
Study Chair: John Suh, MD Cleveland Clinic
  More Information

No publications provided

Study ID Numbers: ENRICH Study, Brain Metastases, Breast Cancer
Study First Received: May 18, 2004
Last Updated: November 2, 2007
ClinicalTrials.gov Identifier: NCT00083304     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Allos Therapeutics:
Breast
Brain
RSR13
efaproxiral
Whole Brain Radiation Therapy
Brain metastases
Metastatic breast cancer

Additional relevant MeSH terms:
Antisickling Agents
Skin Diseases
Physiological Effects of Drugs
Hematologic Agents
Breast Neoplasms
Pharmacologic Actions
Efaproxiral
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Neoplasm Metastasis
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009