Metastatic Malignant Neoplasm in the Adult BrainEarly Phase 1NCT02338037
Neuropharmacokinetics of Eribulin Mesylate in Treating Patients With Primary or Metastatic Brain Tumors
A Early Phase 1 study testing Therapeutic Conventional Surgery, Biopsy and Eribulin Mesylate in people with Metastatic Malignant Neoplasm in the Adult Brain and Primary Brain Tumor, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This pilot trial studies the brain concentration of eribulin mesylate in treating patients with primary or metastatic brain tumors. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm in the Adult Brain, Primary Brain Tumor
- What is being tested?
- Therapeutic Conventional Surgery, Biopsy and Eribulin Mesylate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2015to 15 Mar 2024
- Phase
- Early 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
- Patients must have a Karnofsky performance status of >= 60
- Brain tumor patient is planning to undergo tumor resection or biopsy for the purpose of differentiating between tumor progression versus treatment-induced effects following radiation therapy and/or chemotherapy
- If a patient has magnetic resonance imaging (MRI) findings consistent with tumor but does not already have a histopathologic diagnosis of cancer, s/he may sign the consent form, but final eligibility for study enrollment will be determined based on results of the frozen section at time of surgery
- Patient may have received previous treatment for the brain tumor(s), including radiation (focal brain radiation, whole brain radiation or stereotactic radiosurgery), surgery or chemotherapy
- There is no limit to the number of prior chemotherapies
- Patients who have previously been treated with eribulin are allowed to participate in the microdialysis portion of the study only
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- Absolute neutrophil count of > 1500 cells/mm^3
- Platelet count > 100,000 cells/mm^3
- Total bilirubin < 2.0 mg/dl
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) < 3 times the institutional upper limit of normal
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 3 times the institutional upper limit of normal
- Serum creatinine < 1.5 x the institutional upper limit of normal
- All subjects must have the ability to understand and the willingness to sign a written informed consent
- Patients must have sufficiently recovered (=< grade 1) from any toxicity of prior therapy; the required waiting period between the last dose of the most recent chemotherapy agent and the first dose of eribulin will be determined based on the half-life of the chemotherapy agent; the minimum time between stopping prior therapy and administering the first dose of eribulin should be 3.3 half-lives with the following exceptions: an interval of at least 6 weeks must elapse since treatment with a nitrosourea and at least 4 weeks since the last dose of bevacizumab
- If corticosteroids are required for controlling cerebral edema, patients must be on a stable dose of at least 1 week prior to enrollment
- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for 3 months following duration of study participation; women of child-bearing potential must have a negative serum pregnancy test prior to enrollment; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
Who cannot join
- Patients who are currently receiving chemotherapy, radiation therapy or are enrolled in another therapeutic clinical trial
- Patients who have not recovered from the toxicities of prior chemotherapy or radiation
- Patients who are taking any of the prohibited medications; if a patient is willing to discontinue such a medication in order to participate in the study, then there must be an appropriate washout period, based on the half-life of the particular drug, prior to the start of the study treatment
- Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines, unstable angina or myocardial infarction within the previous 6 months
- Clinically significant cardiac arrhythmias, prolonged QT interval, congenital long QT syndrome
- Patients who cannot undergo brain magnetic resonance imaging (MRIs)
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- Patients with existing grade 3 or 4 peripheral neuropathy
- Patients who have a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol or may not be able to comply with the safety monitoring requirements of the study
- Female patients who are pregnant or breast-feeding
- Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals
- Non-compliance: subjects who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: An Intracerebral Microdialysis Study to Determine the Neuropharmacokinetics of Eribulin in Patients With Brain Tumors
This pilot trial studies the brain concentration of eribulin mesylate in treating patients with primary or metastatic brain tumors. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Collecting small samples of brain fluids may help determine how well eribulin mesylate concentrates into the brain tumor.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the neuropharmacokinetic (nPK) profile of eribulin (eribulin mesylate) using intracerebral microdialysis.
SECONDARY OBJECTIVES:
- To compare concentrations of eribulin in tumor (enhancing tissue) and normal brain (non-enhancing tissue) when technically feasible to place two microdialysis catheters in a study patient.
II. To describe the intracerebral clinical benefit (defined as stable disease, partial response, or complete response) of eribulin in study patients who continue to be treated with eribulin after completing the microdialysis portion of the study.
III. To document the toxicity of eribulin in the cohort of patients.
OUTLINE:
Patients undergo tumor resection or biopsy and have microdialysis catheter placed on day 0. Beginning at least 24 hours later, patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on day 1. Serial brain fluid samples are collected for approximately 72 hours and the microdialysis catheter is then removed. Beginning at least 2 weeks after tumor resection or biopsy, patients may continue to receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
- Being tested
- Therapeutic Conventional Surgery, Biopsy, Eribulin Mesylate, Microdialysis, Pharmacological Study
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Conventional SurgeryProcedure or surgery
Undergo tumor resection
BiopsyProcedure or surgery
Also called Bx
Undergo biopsy
Eribulin MesylateDrug
Also called E7389, ER-086526
Given IV
MicrodialysisProcedure or surgery
Undergo intracerebral microdialysis
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (eribulin mesylate) | Experimental | Patients undergo tumor resection or biopsy and have microdialysis catheter placed on day 0. Beginning at least 24 hours later, patients receive eribulin mesylate IV over 2-5 minutes on day 1. Serial brain fluid samples are collected for approximately 72 hours and the microdialysis catheter is then removed. Beginning at least 2 weeks after tumor resection or biopsy, patients may continue to receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Therapeutic Conventional Surgery; Procedure: Biopsy; Drug: Eribulin Mesylate; Procedure: Microdialysis; Other: Pharmacological Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of maximum concentration observed (Tmax) for eribulin mesylate
Pharmacokinetic data will be summarized by using descriptive statistics and graphical methods. The pharmacokinetic parameters will be calculated on the log scale along with means and 95% confidence limits based on a t distribution.
Measured: Baseline, at 5, 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours and then 1 week after the infusion of eribulin mesylate
Maximum concentration observed (Cmax) for eribulin mesylate
Pharmacokinetic data will be summarized by using descriptive statistics and graphical methods. The pharmacokinetic parameters will be calculated on the log scale along with means and 95% confidence limits based on a t distribution.
Measured: Baseline, at 5, 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours and then 1 week after the infusion of eribulin mesylate
Area under the curve (AUC) for eribulin mesylate
Pharmacokinetic data will be summarized by using descriptive statistics and graphical methods. The pharmacokinetic parameters will be calculated on the log scale along with means and 95% confidence limits based on a t distribution.
Measured: Baseline, at 5, 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours and then 1 week after the infusion of eribulin mesylate
Half-life (t1/2) for eribulin mesylate
Measured: Baseline, at 5, 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours and then 1 week after the infusion of eribulin mesylate
Ratio of AUC of eribulin mesylate in dialysate to plasma
Measured: Baseline, at 5, 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours and then 1 week after the infusion of eribulin mesylate
Secondary outcomes (2)
Toxicity profile of eribulin mesylate graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Will be summarized in tabular form by adverse event category, grade, and attribution.
Measured: Up to 30 days
Clinical benefit rate defined as tumor response on brain MRI results
Clinical benefit rate and associated 95% confidence limits will be calculated based on data from participants that receive at least 2 courses of eribulin mesylate.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study start16 Sep 2015
- Primary completion4 Aug 2017
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Malignant Neoplasm in the Adult BrainStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Jana Portnow, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338037
- Sponsor's protocol ID
- 14312
- Other IDs
- NCI-2014-02391, 14312
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2014
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eroglu Z, Synold T, Badie B, Liu A, Chowdhury A, Kilpatrick J, Blanchard S, Portnow J. An intracerebral microdialysis study to determine the neuropharmacokinetics of eribulin in patients with metastatic or primary brain tumors. Cancer Chemother Pharmacol. 2024 Dec;94(6):807-813. doi: 10.1007/s00280-024-04711-2. Epub 2024 Oct 18.
PubMed 39422741
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intracerebral Microdialysis Study to Determine the Neuropharmacokinetics of Eribulin in Patients With Brain Tumors
- ClinicalTrials.gov ID
- NCT02338037
- Acronym / sponsor ID
- 14312
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Eisai Inc.
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 14 Jan 2015 (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.
This pilot trial studies the brain concentration of eribulin mesylate in treating patients with primary or metastatic brain tumors. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Collecting small samples of brain fluids may help determine how well eribulin mesylate concentrates into the brain tumor.
Detailed description
PRIMARY OBJECTIVES:
- To determine the neuropharmacokinetic (nPK) profile of eribulin (eribulin mesylate) using intracerebral microdialysis.
SECONDARY OBJECTIVES:
- To compare concentrations of eribulin in tumor (enhancing tissue) and normal brain (non-enhancing tissue) when technically feasible to place two microdialysis catheters in a study patient.
II. To describe the intracerebral clinical benefit (defined as stable disease, partial response, or complete response) of eribulin in study patients who continue to be treated with eribulin after completing the microdialysis portion of the study.
III. To document the toxicity of eribulin in the cohort of patients.
OUTLINE:
Patients undergo tumor resection or biopsy and have microdialysis catheter placed on day 0. Beginning at least 24 hours later, patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on day 1. Serial brain fluid samples are collected for approximately 72 hours and the microdialysis catheter is then removed. Beginning at least 2 weeks after tumor resection or biopsy, patients may continue to receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (eribulin mesylate) | Experimental | Procedure: Therapeutic Conventional Surgery, Procedure: Biopsy, Drug: Eribulin Mesylate, Procedure: Microdialysis, Other: Pharmacological StudyPatients undergo tumor resection or biopsy and have microdialysis catheter placed on day 0. Beginning at least 24 hours later, patients receive eribulin mesylate IV over 2-5 minutes on day 1. Serial brain fluid samples are collected for approximately 72 hours and the microdialysis catheter is then removed. Beginning at least 2 weeks after tumor resection or biopsy, patients may continue to receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have a Karnofsky performance status of >= 60
- Brain tumor patient is planning to undergo tumor resection or biopsy for the purpose of differentiating between tumor progression versus treatment-induced effects following radiation therapy and/or chemotherapy
- Patient may have received previous treatment for the brain tumor(s), including radiation (focal brain radiation, whole brain radiation or stereotactic radiosurgery), surgery or chemotherapy
- There is no limit to the number of prior chemotherapies
- Patients who have previously been treated with eribulin are allowed to participate in the microdialysis portion of the study only
Key exclusion criteria (11 listed)
- Patients who are currently receiving chemotherapy, radiation therapy or are enrolled in another therapeutic clinical trial
- Patients who have not recovered from the toxicities of prior chemotherapy or radiation
- Patients who are taking any of the prohibited medications; if a patient is willing to discontinue such a medication in order to participate in the study, then there must be an appropriate washout period, based on the half-life of the particular drug, prior to the start of the study treatment
- Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines, unstable angina or myocardial infarction within the previous 6 months
- Clinically significant cardiac arrhythmias, prolonged QT interval, congenital long QT syndrome
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 |
|---|---|---|
| Therapeutic Conventional SurgeryUndergo tumor resection | Procedure or surgery | Treatment (eribulin mesylate) |
| BiopsyAlso: BxUndergo biopsy | Procedure or surgery | Treatment (eribulin mesylate) |
| Eribulin MesylateAlso: E7389, ER-086526Given IV | Drug | Treatment (eribulin mesylate) |
| MicrodialysisUndergo intracerebral microdialysis | Procedure or surgery | Treatment (eribulin mesylate) |
| Pharmacological StudyAlso: pharmacological studiesCorrelative studies | Other | Treatment (eribulin mesylate) |
Primary outcome
Time of maximum concentration observed (Tmax) for eribulin mesylate
Time frame: Baseline, at 5, 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours and then 1 week after the infusion of eribulin mesylate
Pharmacokinetic data will be summarized by using descriptive statistics and graphical methods. The pharmacokinetic parameters will be calculated on the log scale along with means and 95% confidence limits based on a t distribution.
Maximum concentration observed (Cmax) for eribulin mesylate
Time frame: Baseline, at 5, 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours and then 1 week after the infusion of eribulin mesylate
Pharmacokinetic data will be summarized by using descriptive statistics and graphical methods. The pharmacokinetic parameters will be calculated on the log scale along with means and 95% confidence limits based on a t distribution.
Area under the curve (AUC) for eribulin mesylate
Time frame: Baseline, at 5, 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours and then 1 week after the infusion of eribulin mesylate
Pharmacokinetic data will be summarized by using descriptive statistics and graphical methods. The pharmacokinetic parameters will be calculated on the log scale along with means and 95% confidence limits based on a t distribution.
Half-life (t1/2) for eribulin mesylate
Time frame: Baseline, at 5, 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours and then 1 week after the infusion of eribulin mesylate
Ratio of AUC of eribulin mesylate in dialysate to plasma
Time frame: Baseline, at 5, 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours and then 1 week after the infusion of eribulin mesylate
2 secondary outcomes
Toxicity profile of eribulin mesylate graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 30 days
Clinical benefit rate defined as tumor response on brain MRI results
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 39422741Eroglu Z, Synold T, Badie B, Liu A, Chowdhury A, Kilpatrick J, Blanchard S, Portnow J. An intracerebral microdialysis study to determine the neuropharmacokinetics of eribulin in patients with metastatic or primary brain tumors. Cancer Chemother Pharmacol. 2024 Dec;94(6):807-813. doi: 10.1007/s00280-024-04711-2. Epub 2024 Oct 18.
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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.
Jana Portnow, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Therapeutic Conventional Surgery, Biopsy and Eribulin Mesylate in people with Metastatic Malignant Neoplasm in the Adult Brain and Primary Brain Tumor, run by City of Hope Medical Center at 1 site 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 16 inclusion and 11 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: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time of maximum concentration observed (Tmax) for eribulin mesylate (time frame: Baseline, at 5, 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours and then 1 week after the infusion of eribulin mesylate). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02338037, which also lists 1 linked publication.
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 13 Oct 2026.