A Phase 1 interventional study of lithium carbonate and cognitive assessment in Brain and Central Nervous System Tumors, Cognitive/Functional Effects and Neurotoxicity, sponsored by Vanderbilt-Ingram Cancer Center. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-28.
Sponsored by Vanderbilt-Ingram Cancer Center · Phase 1, Interventional, and Supportive care
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:
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 9 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Histopathologically confirmed extracranial primary malignancy
Exclusion Criteria:
Neurologically stable
PRIOR CONCURRENT THERAPY:
Drug: lithium carbonate · Procedure: cognitive assessment · Procedure: quality-of-life assessment · Radiation: radiation therapy
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
Also known as: lithium
cognitive assessment
quality-of-life assessment
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.
Feasibility of concurrent lithium carbonate and whole-brain radiotherapy as measured by safety and compliance
Time frame: Safety is measured by the rate of grade 3 or worse
This study is terminated, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Vanderbilt-Ingram Cancer Center