Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
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.