NCT00892801

Everolimus and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastasis From Non-Small Cell Lung Cancer

A Phase I/II Study of RAD001 and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving everolimus together with whole-brain radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus and to see how well it works when given together with whole-brain radiation therapy in treating patients with brain metastasis from non-small cell lung cancer.

Detailed description

Phase I is intended to determine the maximum tolerated dose. Study drug will be administered orally, once a day, for 15 days, one day prior to initiation of WBRT at 5 or 10 mg/day during the phase I component. One of these doses will be selected as the maximum tolerable dose and will be selected for the phase II component. OBJECTIVES: Primary * To determine the maximum-tolerated dose of everolimus when combined concurrently with whole-brain radiotherapy in patients with brain metastasis from stage IV non-small cell lung cancer. (Phase I) * To evaluate the median survival of these patients treated with this regimen. (Phase II) Secondary * To assess the response rates in these patients. (Phase II) * To assess the safety and tolerability of this regimen in these patients. (Phase II) * To determine time to CNS (neurological) progression, confirmed by MRI, in these patients. (Phase II) * To determine time to systemic (non-CNS) progression in these patients. (Phase II) OUTLINE: This is a multicenter, dose-escalation study of everolimus. Patients undergo 10 fractions of whole-brain radiotherapy (WBRT) beginning on day 0, 5 days per week, and receive oral everolimus once daily on days -1 to 13. Beginning 2 weeks after completion of WBRT, patients receive oral everolimus once daily for 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 2 months for 2 years.

Conditions

• Lung Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	RAD001	Taken by mouth once a day, for 15 days, one day prior to initiation of whole brain radiation therapy at 5 or 10 mg/day during the phase I component. One of these doses will be selected as the maximum tolerable dose and will be selected for the phase II component
RADIATION	whole-brain radiation therapy	Standard whole brain radiation therapy (WBRT) 30 Gy will be given in ten fractions.

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2009-05-05
• Last updated: 2012-03-12

Locations

2 sites across 1 country: United States