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Status:

TERMINATED

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

Lead Sponsor:

Vanderbilt-Ingram Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain and Central Nervous System Tumors

Cognitive/Functional Effects

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief 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 radi...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

9 Patients enrolled

Trial Details

Trial ID

NCT00469937

Start Date

February 1 2006

End Date

March 1 2009

Last Update

February 28 2012

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, United States, 37064

2

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, United States, 37064

3

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States, 37232-6838