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

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Lithium Carbonate

Criteria

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

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

• No concurrent radiotherapy to other sites

• No concurrent anticonvulsants due to brain metastases

• No concurrent psychoactive drugs

• No concurrent thyroid medications

• No concurrent amifostine