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| 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 |
| Estimated Enrollment: | 360 |
| Study Start Date: | February 2004 |
| Study Completion Date: | June 2007 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study 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 | |
| Study Chair: | John Suh, MD | Cleveland Clinic |
More Information
| 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 |
|
Breast Brain RSR13 efaproxiral |
Whole Brain Radiation Therapy Brain metastases Metastatic breast cancer |
|
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 |