NCT00469937

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 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2006

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

3.1 years

First QC Date

May 3, 2007

Last Update Submit

February 26, 2012

Conditions

Brain and Central Nervous System TumorsCognitive/Functional EffectsNeurotoxicitySolid Tumor

Keywords

radiation toxicityneurotoxicitycognitive/functional effectsunspecified adult solid tumor, protocol specificadult tumors metastatic to brain

Outcome Measures

Primary Outcomes (1)

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

    Safety is measured by the rate of grade 3 or worse

Study Arms (1)

Therapeutic Intervention

EXPERIMENTAL
Drug: lithium carbonateProcedure: cognitive assessmentProcedure: quality-of-life assessmentRadiation: radiation therapy

Interventions

lithium carbonateDRUG

Dose levels Neoadjuvant lithium Concurrent lithium Dose level -1 300mg po QD 300mg po QD Dose level (starting dose) 300mg po BID 300mg po BID Dose level 2 300mg po TID 300mg po TID Dose level 3 300mg po QID 300mg po QID

Also known as: lithium
Therapeutic Intervention
cognitive assessmentPROCEDURE

cognitive assessment

Therapeutic Intervention
quality-of-life assessmentPROCEDURE

quality-of-life assessment

Therapeutic Intervention
radiation therapyRADIATION

Protocol radiotherapy must begin within seven days following initiation of Lithium therapy if day seven falls on a holiday or weekend; it is acceptable to begin treatment the next business day. One treatment of 3Gy will be given daily with the exception of weekends and holidays for a total of (10 fractions) for a total of 30 Gy over 2 to 3 weeks.

Therapeutic Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsNeurotoxicity SyndromesRadiation InjuriesBrain Neoplasms

Interventions

Lithium CarbonateLithiumMental Status and Dementia TestsRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesPoisoningChemically-Induced DisordersWounds and InjuriesBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

CarbonatesAlkaliesInorganic ChemicalsCarbonic AcidCarbon Compounds, InorganicLithium CompoundsMetals, AlkaliElementsMetals, LightMetalsNeuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesTherapeutics

Study Officials

  • Bo Lu, MD, PhD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor; Radiation Oncologist

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 7, 2007

Study Start

February 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

US(3)