A Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Primary Brain Tumors
Oliver Jonas
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.
Description
This research study is a Pilot Study, which is the first time investigators are examining this study device in brain tumors. The FDA (the U.S. Food and Drug Administration) has not approved the microdevice as a treatment for any disease. Investigators are studying the safety of the microdevice and the effects of different drugs for each specific tumor. Brain tumors are known to be very different from each other and respond differently to different drugs. It would be very helpful to find out what drugs have the best chance of working in each specific tumor. This research study involves drugs…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have operable supratentorial tumor presumed to be WHO grade II-IV glioma (Astrocytoma, Oligodendroglioma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, or Glioblastoma) based on radiological evidence at MRI, where a gross total or partial surgical resection is intended. * Histological confirmation of WHO grade II-IV glioma at time of intraoperative frozen analysis (for newly diagnosed tumors). This is not necessary in cases where a histopathologic diagnosis is already available from prior surgeries/biopsies. * Participants must be 18 years of age or…
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.
Location
- Brigham and Women's HospitalBoston, Massachusetts