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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 Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer Clinical research trials and Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer. Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer clinical trial. Human subjects often get the best healthcare available for their Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer  Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer
Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer
For Condition: Metastatic breast cancer
Status: Recruiting
Sponsor(s): Allos Therapeutics ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry 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
Total Enrollment: 360
Location and Contact Information:
Overall Study Official:
JohnSuh, Study Chair, Cleveland Clinic
University of Minnesota Fairview University Medical Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Amy Deyle 612-626-3261
Virginia G. Piper Cancer Center, Arizona Oncology Services *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting Terry Thomas 602-274-4484
Emory University Winship Cancer Institute *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Ellen McKenzie 404-778-5344
Avera McKennan Hospital and University Medical Center *Recruiting*
Sioux Falls, South Dakota, 57105
United States
Recruiting Jessica Larsen-Gallup 605-322-3086
Oncology Alliance of Milwaukee *Recruiting*
Milwaukee, Wisconsin, 53215-3669
United States
Recruiting Barb Knutson 414-416-1752
Hotel-Dieu de Quebec du CHUQ *Recruiting*
Quebec City, Quebec, G1R 5C3
Canada
Recruiting Josee Allard (418) 691-5264
North Idaho Cancer Center *Recruiting*
Coeur D Alene, Idaho, 83814
United States
Recruiting Tolli Wilhitte 208-666-3764
Lexington Clinic Cancer Center *Recruiting*
Lexington, Kentucky, 40504
United States
Recruiting Linda Wilgus 859-258-6505
Dent Neurologic Institute *Recruiting*
Amherst, New York, 14226
United States
Recruiting Malika Pasha 716-250-2028
Arizona Cancer Center, University of Arizona *Recruiting*
Tucson, Arizona, 85724-5081
United States
Recruiting Jamie Holt 520-626-6800
CHUM - Campus Notre Dame *Recruiting*
Montreal, Quebec, H2L 4M1
Canada
Recruiting Diane Alarie (514) 890-8000
Alta Bates Comprehensive Cancer Center *Recruiting*
Berkeley, California, 94704
United States
Recruiting Beth Davis 510-204-3428
Hopital Maisonneuve-Rosemont *Recruiting*
Montreal, Quebec, H1T 2M4
Canada
Recruiting Linda Roy-Huneault (514) 252-3400
Bismarck Cancer Center *Recruiting*
Bismark, North Dakota, 58501
United States
Recruiting Julie Wetzstein 701-530-6960
Cross Cancer Center *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting Shelly Sass (780) 432-8595
Additional Information:
Study ID Numbers: ENRICH Study; Brain Metastases,Breast Cancer
Study Start Date: February 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083304
Other Metastatic Breast Cancer Studies:
1. Capecitabine (Xeloda) With Or Without GW572016 For Women With Refractory Advanced Or Metastatic Breast Cancer
2. An Investigational Drug versus Capecitabine in Male or Female Patients with Advanced Breast Cancer
3. Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer
4. Paclitaxel With Or Without GW572016 As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
5. Pegylated Liposomal Doxorubicin compared to Capecitabine in treating Women 65 Years and Older with Metastatic Breast Cancer
Related Studies:
Other Metastatic breast cancer Clinical Trials
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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
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