Radiation Therapy in Combination With Indinavir / Ritonavir (Crixivan / Norvir) for the Treatment of Brain Metastases: a Randomized Phase II Study
OBJECTIVES:
- 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
radiotherapy alone.
- Prospectively investigate the efficacy of a potentially antiangiogenic agent, indinavir
sulfate.
- 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
months.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Time to treatment failure in the brain (TTF) as determined by the radiological response rate
No
Ilja Ciernik, MD
Principal Investigator
Oncology Institute of Southern Switzerland
Unspecified
CDR0000587517
NCT00637637
September 2007
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