External-Beam Radiation Therapy With or Without Indinavir and Ritonavir in Treating Patients With Brain Metastases
Recruitment status was: Recruiting
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Indinavir and ritonavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether external-beam radiation therapy is more effective with or without indinavir and ritonavir in treating patients with brain metastases.
PURPOSE: This randomized phase II trial is studying external-beam radiation therapy alone to see how well it works compared to external-beam radiation therapy given together with indinavir and ritonavir in treating patients with brain metastases.
Drug: indinavir sulfate
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Radiation Therapy in Combination With Indinavir / Ritonavir (Crixivan / Norvir) for the Treatment of Brain Metastases: a Randomized Phase II Study|
- Time to treatment failure in the brain (TTF) as determined by the radiological response rate [ Designated as safety issue: No ]
- Overall survival (OS) [ Designated as safety issue: No ]
- Radiological volumetric response to treatment [ Designated as safety issue: No ]
- Local intracranial disease progression at 4 months [ Designated as safety issue: No ]
- Progression-free survival at 6 months [ Designated as safety issue: No ]
- Improvement of symptoms [ Designated as safety issue: No ]
- Time to symptom relapse or symptom progression [ Designated as safety issue: No ]
- Duration of use of steroids [ Designated as safety issue: No ]
- Duration of use of anticonvulsive drugs [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637637
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|Oncology Institute of Southern Switzerland - Lugano|
|Lugano, Switzerland, CH-6900|
|Zurich, Switzerland, CH-8091|
|Principal Investigator:||Ilja Ciernik, MD||Oncology Institute of Southern Switzerland|