Brain and Central Nervous System TumorsPhase 1NCT00469937
Ph I Study of Lithium During Whole Brain Radiotherapy For Patients With Brain Metastases
A Phase 1 study testing lithium carbonate, cognitive assessment and quality-of-life assessment in people with Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Neurotoxicity
- What is being tested?
- lithium carbonate, cognitive assessment and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2006to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: A Phase I Study of Lithium During Whole Brain Radiotherapy for Patients With Brain Metastases
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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Neurotoxicity, Solid Tumor
- Being tested
- lithium carbonate, cognitive assessment, quality-of-life assessment, radiation therapy
- Keywords
- radiation toxicity, neurotoxicity, cognitive/functional effects, unspecified adult solid tumor, protocol specific, adult tumors metastatic to brain
- Medical subject headings
- Central Nervous System Neoplasms, Neurotoxicity Syndromes, Radiation Injuries, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lithium carbonateDrug
Also called lithium
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
cognitive assessmentProcedure or surgery
cognitive assessment
quality-of-life assessmentProcedure or surgery
quality-of-life assessment
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Intervention | Experimental | Not described Receives: Drug: lithium carbonate; Procedure: cognitive assessment; Procedure: quality-of-life assessment; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of concurrent lithium carbonate and whole-brain radiotherapy as measured by safety and compliance
Measured: Safety is measured by the rate of grade 3 or worse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startFeb 2006
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, David Gius, MD, PhD, Vanderbilt-Ingram Cancer Center
- Investigators
- Bo Lu, MD, PhD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469937
- Sponsor's protocol ID
- VICC RAD 0521
- Other IDs
- VU-VICC-RAD-0521, VU-IRB-051043
- Status last verified
- Feb 2012
- First submitted
- 3 May 2007
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Lithium During Whole Brain Radiotherapy for Patients With Brain Metastases
- ClinicalTrials.gov ID
- NCT00469937
- Acronym / sponsor ID
- VICC RAD 0521
- Conditions
- Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Neurotoxicity, Solid Tumor
- Keywords
- radiation toxicity, neurotoxicity, cognitive/functional effects, unspecified adult solid tumor, protocol specific, adult tumors metastatic to brain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 7 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Intervention | Experimental | Drug: lithium carbonate, Procedure: cognitive assessment, Procedure: quality-of-life assessment, Radiation: radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histopathologically confirmed extracranial primary malignancy
- No requirement for immediate whole-brain radiotherapy
- No metastases to the midbrain or brainstem
Key exclusion criteria (30 listed)
- Zubrod performance status 0-2
- Life expectancy ≥ 8 weeks
- Platelet count > 100,000/mm^3
- ANC > 1,500/mm^3
- Hemoglobin ≥ 10 g/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lithium carbonateAlso: lithiumDose 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 | Drug | Therapeutic Intervention |
| cognitive assessmentcognitive assessment | Procedure or surgery | Therapeutic Intervention |
| quality-of-life assessmentquality-of-life assessment | Procedure or surgery | Therapeutic Intervention |
| radiation therapyProtocol 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. | Radiation | Therapeutic Intervention |
Primary outcome
Feasibility of concurrent lithium carbonate and whole-brain radiotherapy as measured by safety and compliance
Time frame: Safety is measured by the rate of grade 3 or worse
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Lu, MD, PhD principal investigator
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lithium carbonate, cognitive assessment and quality-of-life assessment in people with Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of concurrent lithium carbonate and whole-brain radiotherapy as measured by safety and compliance (time frame: Safety is measured by the rate of grade 3 or worse). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.