A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases

OBJECTIVES:

• Compare the median survival time in patients with brain metastases after receiving treatment with whole brain radiotherapy with or without RSR13.
• Compare the response rate to these treatment regimens in these patients.
• Compare the time to progression after receiving these treatment regimens in these patients.
• Compare quality of life in these patients receiving these treatment regimens.
• Compare cause of death (neurologic vs nonneurologic death) in these patients after receiving these treatment regimens.
• Determine the safety of RSR13 in these patients.
• Assess the pharmacokinetics of RSR13 in these patients.

OUTLINE: This is a randomized, open label, comparative, multicenter study. Patients are stratified according to the Radiation Therapy Oncology Group RPA Class (I vs II). Patients are further stratified within the RPA class II stratum according to site of primary cancer (non-small cell lung cancer vs breast vs other). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive whole brain radiotherapy 5 days a week for two weeks in conjunction with supplemental oxygen breathing.
• Arm II: Patients receive RSR13 IV over 30 minutes followed by whole brain radiotherapy and supplemental oxygen breathing as in arm I.

Quality of life is assessed at the first and last day of radiotherapy, at 1 month, 3 months, and then every 3 months until disease progression.