External-Beam Radiation Therapy With or Without Indinavir and Ritonavir in Treating Patients With Brain Metastases

Phase 2

• Conditions: Cancer

• Registration Number: NCT00637637
• Lead Sponsor: Oncology Institute of Southern Switzerland

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-03-14
• Study First Submitted QC: 2008-03-14
• Study First Posted: 2008-03-18
• Status Verified: 2008-12
• Primary Completion: 2009-06
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to treatment failure in the brain (TTF) as determined by the radiological response rate
Local intracranial disease progression at 4 months
Radiological volumetric response to treatment
Overall survival (OS)
Progression-free survival at 6 months

Secondary Outcome Measures

Name	Time	Method
Duration of use of anticonvulsive drugs
Time to symptom relapse or symptom progression
Improvement of symptoms
Duration of use of steroids

Trial Locations

Locations (3)

Hopital Cantonal Universitaire de Geneve; 🇨🇭 Geneva, Switzerland

UniversitaetsSpital Zuerich; 🇨🇭 Zurich, Switzerland

Oncology Institute of Southern Switzerland - Lugano; 🇨🇭 Lugano, Switzerland