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


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Neurotoxicity, Solid Tumor

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Safety is measured by the rate of grade 3 or worse

Safety Issue:

Yes

Principal Investigator

Bo Lu, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

VICC RAD 0521

NCT ID:

NCT00469937

Start Date:

February 2006

Completion Date:

March 2009

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Cognitive/Functional Effects
  • Neurotoxicity
  • Solid Tumor
  • radiation toxicity
  • neurotoxicity
  • cognitive/functional effects
  • unspecified adult solid tumor, protocol specific
  • adult tumors metastatic to brain
  • Neoplasm Metastasis
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neurotoxicity Syndromes

Name

Location

Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool Springs Nashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at Franklin Nashville, Tennessee  37064