RecruitingEarly Phase 1NCT04135807

Implantable Microdevice In Primary Brain Tumors

A Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Primary Brain Tumors


Sponsor

Oliver Jonas

Enrollment

12 participants

Start Date

Mar 3, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This pilot study will assess the safety and feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in malignant brain tumors. * The device involved in this study is called a microdevice. * The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a tiny implantable device placed directly into a brain tumor during surgery, which releases very small amounts of multiple drugs to test which ones are most effective at treating the tumor in each individual patient. **You may be eligible if...** - You are 18 or older - You have a brain tumor (glioma, grade II-IV) that is being surgically removed - Your overall health and performance level are adequate (Karnofsky Performance Score ≥ 60) - Your blood counts and organ function are within acceptable levels - You agree to use contraception during the study **You may NOT be eligible if...** - Your tumor is smaller than 5 cm³ or located in deep brain structures (like the thalamus or brainstem) - You have had chemotherapy or radiation within the past 4 weeks - You have an active infection, significant heart problems, or other serious uncontrolled illness - You have a bleeding disorder that cannot be corrected - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTMicrodevice

Placement of 1-3 microdevices (depending on the size of the tumor) before tumor resection is started. The microdevices will dwell in the tumor tissue for a time window of 2-4 hours to allow time for tissue effects of the drugs (Temozolomide, Lomustine, Irinotecan, Carboplatin, Lapatinib, Osimertinib, Abenaciclib, and Everolimus) released by the microdevice reservoirs. The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.


Locations(1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT04135807


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