Radiation Therapy in Combination With Indinavir / Ritonavir (Crixivan / Norvir) for the Treatment of Brain Metastases: a Randomized Phase II Study
- Compare the efficacy, in terms of time to treatment failure at CNS level and 4-months
treatment failure rate, in patients with brain metastases treated with external-beam
radiotherapy in combination with indinavir sulfate and ritonavir versus external-beam
- Prospectively investigate the efficacy of a potentially antiangiogenic agent, indinavir
- Investigate the antineoplastic activity of indinavir sulfate in combination with
ionizing radiation in cancer patients with metastatic disease to the brain.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy to the brain once daily, 5 days a week for 2 weeks
(10 doses total). Patients also receive oral indinavir sulfate and oral ritonavir twice
daily for 35 days beginning at day 1 of radiotherapy.
- Arm II: Patients undergo radiotherapy to the brain once daily, 5 days a week for 2
weeks (10 doses total).
Patients complete quality of life questionnaires, including QOL-30 and the Mini Mental
Status Examination, at baseline, 2 weeks after completion of radiotherapy, and at 1 and 3
months after completion of study treatment.
After completion of study treatment, patients are followed periodically for at least 4
Allocation: Randomized, Primary Purpose: Treatment
Time to treatment failure in the brain (TTF) as determined by the radiological response rate
Ilja Ciernik, MD
Oncology Institute of Southern Switzerland