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