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.
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 that are released by a small device, as small as the tip of a needle, that is inserted into the tumor at the time of surgery and is removed at the end of the surgery. The goal of this research study is to prove that microdevices can be used to find out which drugs have better effects on treating malignant brain tumors. Participants will be in this research study for up to 30 days. Expected enrollment is about 12 people.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
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.
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGSuccess Rate of Microdevice Retrieval
Defined as the ability to retrieve the microdevice with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation of at least 50% of the microdevice reservoirs.
Time frame: 1 day
Number of Participants with Microdevice Related Adverse Events as Assessed by CTCAE Volume 5.0
Failure" from a safety standpoint will be considered any of the following: * Any grade 3 or higher adverse events associated with microdevice placement or retrieval. * Any combination of more than two grade 2 adverse events. Failure" from a safety standpoint will be considered any of the following:
Time frame: 1 Day
Measure Local Intratumor Response to Different Agents
two-tailed alpha level of 0.05 and report 95% confidence intervals with any point estimates
Time frame: 1 Day
Correlate Tissue Genetic Features with Drug Response
Preliminary correlations between a specific genetic feature and drug response will be tested using the Chi-squared/Fisher's exact test for categorical variables or the T-test or Wilcoxon Rank-Sum test for continuous variables.
Time frame: 1 Day
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