A Phase I Study of Lithium During Whole Brain Radiotherapy for Patients With Brain Metastases
- 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
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Feasibility of concurrent lithium carbonate and whole-brain radiotherapy as measured by safety and compliance
Safety is measured by the rate of grade 3 or worse
Bo Lu, MD, PhD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC RAD 0521
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|
|Vanderbilt-Ingram Cancer Center at Franklin||Nashville, Tennessee 37064|