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

Stopped early · Phase 1

Conditions studied: Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Neurotoxicity, Solid Tumor

In brief

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.

Key facts

Study ID

NCT00469937

Run by

Vanderbilt-Ingram Cancer Center

People needed

9

Starts

2006-02-01

Expected to finish

2009-03-01

Last updated by the study team

2012-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• PRIOR CONCURRENT THERAPY:
• 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

Where it is running

• Vanderbilt-Ingram Cancer Center - Cool Springs — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center at Franklin — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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