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Microtubule Inhibitor

Eribulin Mesylate for Brain Cancer

Phase < 1
Waitlist Available
Led By Jana Portnow, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a Karnofsky performance status of >= 60
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This trial is studying how well eribulin mesylate collects in brain tumors to see if it can help treat them.

Who is the study for?
This trial is for patients with primary or metastatic brain tumors who are planning to undergo surgery or biopsy. They must have stable vital signs, not be pregnant, and agree to use contraception. Prior treatments for the tumor are allowed but they can't currently be on chemotherapy or in another clinical trial.Check my eligibility
What is being tested?
The study tests how well Eribulin Mesylate, a chemotherapy drug, concentrates in brain tumors by analyzing small samples of brain fluid collected during surgery. The goal is to see if this drug effectively reaches the tumor site.See study design
What are the potential side effects?
Eribulin Mesylate may cause side effects like low white blood cell count (increasing infection risk), fatigue, hair loss, numbness or tingling in hands and feet (neuropathy), nausea, and constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You should be able to perform daily activities with a performance status of 60 or higher, according to a scale called Karnofsky.
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If a patient has MRI results showing a possible tumor but hasn't been diagnosed with cancer yet, they can sign the consent form. However, their final eligibility for the study will depend on the results of a tissue sample taken during surgery.
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You are planning to have surgery or biopsy to find out if your brain tumor is getting worse or if it's just a side effect of your treatment.
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You have had treatment for your brain tumor in the past, including radiation, surgery, or chemotherapy. There is no limit to the number of chemotherapy treatments you have had.
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Patients who have taken eribulin before can only take part in the microdialysis part of the study.
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You need to wait for a specific amount of time after finishing your last chemotherapy before starting the new treatment with eribulin, based on the time it takes for the chemotherapy to leave your body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the curve (AUC) for eribulin mesylate
Half-life (t1/2) for eribulin mesylate
Maximum concentration observed (Cmax) for eribulin mesylate
+2 more
Secondary outcome measures
Clinical benefit rate defined as tumor response on brain MRI results
Toxicity profile of eribulin mesylate graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (eribulin mesylate)Experimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Eribulin Mesylate
2014
Completed Phase 4
~3410
Microdialysis
2013
Completed Early Phase 1
~340
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9860

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,443 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,913,976 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
154,091 Total Patients Enrolled

Media Library

Eribulin Mesylate (Microtubule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02338037 — Phase < 1
Brain Tumor Research Study Groups: Treatment (eribulin mesylate)
Brain Tumor Clinical Trial 2023: Eribulin Mesylate Highlights & Side Effects. Trial Name: NCT02338037 — Phase < 1
Eribulin Mesylate (Microtubule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02338037 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies in this exploration of treatments?

"This clinical trial is not accepting participants, as it was last edited on March 16th 2022. However, those seeking to join a medical study can look for other options; 2702 trials are open for brain cancer patients and 37 studies require Microdialysis volunteers."

Answered by AI

What is the upper limit to participant enrollment in this clinical experiment?

"This particular trial is not currently accepting participants, having been last updated on March 16th of 2022. Nonetheless, 2702 clinical trials related to brain cancer and 37 studies pertaining to Microdialysis are actively enrolling patients who meet the criteria."

Answered by AI

Have any prior experiments examined the effects of Microdialysis?

"At the moment, 37 clinical trials researching Microdialysis are in progress with 10 of them being conducted at Phase 3. Although some studies are located in Plano, Texas - 1,225 different sites worldwide have active research projects revolving around this topic."

Answered by AI
~1 spots leftby Mar 2025