Solid Tumor Clinical Trial
Official title:
A Phase I Study of Lithium During Whole Brain Radiotherapy for Patients With Brain Metastases
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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