A Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Primary Brain Tumors
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Grade II Glioma
- Sponsor
- Oliver Jonas
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Number of Participants with Microdevice Related Adverse Events as Assessed by CTCAE Volume 5.0
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief 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.
Detailed 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 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.
Investigators
Oliver Jonas
Associate Professor
Brigham and Women's Hospital
Eligibility Criteria
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 older.
- •Karnofsky Performance Score ≥ 60 (Appendix C).
- •Participants must have normal organ and marrow function as defined below:
- •Leukocytes ≥ 3,000/mcL
- •Absolute neutrophil count ≥ 1,500/mcL
- •Platelets ≥ 100,000/mcL
- •Total bilirubin within normal institutional limits
- •AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal
Exclusion Criteria
- •Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- •Participants who are receiving any other investigational agents.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to the microdevice or any agents used in the study.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded from this study because agents released by the microdevice have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents used in this study, breastfeeding should be discontinued if the mother is treated in the study for a total of 14 days after removal of the microdevice.
- •Tumor size \< 5 cm
- •Tumor located in deep brain structures (e.g. thalamus, brainstem).
- •Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical procedures.
- •If there are significant risk factors (e.g. high risk of venous thrombosis, pulmonary embolism, stroke or myocardial infarction) precluding the safe cessation of anticoagulation medication as per SIR guidelines, patients will be excluded from the trial.
Outcomes
Primary Outcomes
Number of Participants with Microdevice Related Adverse Events as Assessed by CTCAE Volume 5.0
Time Frame: 1 Day
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:
Success Rate of Microdevice Retrieval
Time Frame: 1 day
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.
Secondary Outcomes
- Measure Local Intratumor Response to Different Agents(1 Day)
- Correlate Tissue Genetic Features with Drug Response(1 Day)