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

Information source: Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Neurotoxicity; Solid Tumor

Intervention: lithium carbonate (Drug); cognitive assessment (Procedure); quality-of-life assessment (Procedure); radiation therapy (Radiation)

Phase: Phase 1

Status: Terminated

Sponsored by: Vanderbilt-Ingram Cancer Center

Official(s) and/or principal investigator(s):
Bo Lu, MD, PhD, Principal Investigator, Affiliation: Vanderbilt-Ingram Cancer Center


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.

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Feasibility of concurrent lithium carbonate and whole-brain radiotherapy as measured by safety and compliance

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Histopathologically confirmed extracranial primary malignancy

- Multiple (i. e., > 3) brain metastases OR < 3 metastases with at least 1

metastasis > 4. 0 cm in diameter

- Not eligible for radiosurgery

- No requirement for immediate whole-brain radiotherapy

- No metastases to the midbrain or brainstem

Exclusion Criteria:

- Zubrod performance status 0-2

- Life expectancy ≥ 8 weeks

- Platelet count > 100,000/mm^3

- ANC > 1,500/mm^3

- Hemoglobin ≥ 10 g/dL

- BUN < 25 mg/dL

- Creatinine < 1. 5 mg/dL

- Bilirubin < 1. 5 mg/dL

- ALT ≤ 2 times normal

- Sodium > 136 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Neurologically stable

- No seizure disorders or seizures due to brain metastases

- No medical illnesses or psychiatric conditions that would preclude completion of

study treatment

- No sensory neuropathy ≥ grade 2

- No bipolar disorder

- No thyroid disease

- No QTc interval prolongation


- More than 2 weeks since prior and no concurrent chemotherapy

- At least 2 weeks since prior and no concurrent NSAIDs, angiotensin-converting enzyme

inhibitors (e. g., enalapril or captopril), calcium channel blockers, diuretics, selective cyclooxygenase-2 inhibitors, acetazolamide, urea, xanthine, or alkalinizing agents (e. g., sodium bicarbonate)

- No prior radiotherapy to the head and neck area

- No prior radiosurgery

- No concurrent radiotherapy to other sites

- No concurrent anticonvulsants due to brain metastases

- No concurrent psychoactive drugs

- No concurrent thyroid medications

- No concurrent amifostine

Locations and Contacts

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6838, United States

Vanderbilt-Ingram Cancer Center - Cool Springs, Nashville, Tennessee 37064, United States

Vanderbilt-Ingram Cancer Center at Franklin, Nashville, Tennessee 37064, United States

Additional Information

Starting date: February 2006
Last updated: February 26, 2012

Page last updated: August 23, 2015

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