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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
Be older than 18 years old
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.
Timeline
Screening ~ 3 weeks3 visits
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
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
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 moreSecondary 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
Microdialysis
2013
Completed Early Phase 1
~350
Biopsy
2014
Completed Phase 4
~1090
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Eribulin Mesylate
2014
Completed Phase 4
~3420
Find a Location
Who is running the clinical trial?
Eisai Inc.Industry Sponsor
516 Previous Clinical Trials
159,028 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
569 Previous Clinical Trials
1,924,680 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,363 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious heart rhythm problem or a condition that causes your heart's electrical system to not work properly.You have not fully recovered from the side effects of your previous chemotherapy or radiation treatment.You have severe heart failure, unstable angina, or have had a heart attack in the last 6 months.You are unable to have a brain MRI.You have severe nerve problems in your arms or legs.You have a serious infection that needs to be treated with antibiotics, antivirals, or antifungals.Your absolute neutrophil count is higher than 1500 cells per cubic millimeter.Your platelet count is higher than 100,000 cells per cubic millimeter.Your kidney function test shows a normal level of creatinine in your blood.Your total bilirubin level is less than 2.0 mg/dl.You should be able to perform daily activities with a performance status of 60 or higher, according to a scale called Karnofsky.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.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.Patients who have taken eribulin before can only take part in the microdialysis part of the study.Your AST level in the blood is less than three times the normal limit.Your ALT level in the blood is not more than three times the normal limit for the laboratory where the test is done.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.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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (eribulin mesylate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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