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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.
Sponsored by: 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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Efaproxiral
U.S. FDA Resources
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

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

  Show 49 Study Locations
Sponsors and Collaborators
Allos Therapeutics
Investigators
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  
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

Study placed in the following topic categories:
Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Breast Diseases
Efaproxiral

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

ClinicalTrials.gov processed this record on January 15, 2009