NCT00469937

Ph I Study of Lithium During Whole Brain Radiotherapy For Patients With Brain Metastases

A Phase I Study of Lithium During Whole Brain Radiotherapy for Patients With Brain Metastases

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as lithium, may protect normal cells from the side effects of radiation therapy. Giving lithium together with radiation therapy may allow a higher dose of radiation therapy to be given so that more tumor cells are killed. PURPOSE: This phase I trial is studying the side effects and best dose of lithium when given together with whole-brain radiation therapy in treating patients with brain metastases from primary cancer outside the brain.

Detailed description

OBJECTIVES: * Determine the feasibility of concurrent lithium carbonate and whole-brain radiotherapy, as measured by safety and compliance, in patients with primary extracranial malignancy and brain metastases. OUTLINE: This is an open-label, dose-escalation study of lithium carbonate. Patients receive oral lithium carbonate twice daily on days 1-7 and 2-4 times daily on days 8-21. Patients undergo whole-brain radiotherapy once daily on days 8-12 and 15-19. Cohorts of 3-6 patients receive escalating doses of lithium carbonate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Quality of life and mental status are assessed at baseline, on days 1, 8, and 15, at 1-month post-treatment, and then periodically thereafter. After completion of study treatment, patients are followed at 1 month and then periodically thereafter. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Conditions

• Brain and Central Nervous System Tumors
• Cognitive/Functional Effects
• Neurotoxicity
• Solid Tumor

Interventions

Type	Name	Description
DRUG	lithium carbonate	Dose levels Neoadjuvant lithium Concurrent lithium Dose level -1 300mg po QD 300mg po QD Dose level (starting dose) 300mg po BID 300mg po BID Dose level 2 300mg po TID 300mg po TID Dose level 3 300mg po QID 300mg po QID
PROCEDURE	cognitive assessment	cognitive assessment
PROCEDURE	quality-of-life assessment	quality-of-life assessment
RADIATION	radiation therapy	Protocol radiotherapy must begin within seven days following initiation of Lithium therapy if day seven falls on a holiday or weekend; it is acceptable to begin treatment the next business day. One treatment of 3Gy will be given daily with the exception of weekends and holidays for a total of (10 fractions) for a total of 30 Gy over 2 to 3 weeks.

Timeline

• Start date: 2006-02-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-05-07
• Last updated: 2012-02-28

Locations

3 sites across 1 country: United States