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Microdevice for Brain Cancer
Phase < 1
Recruiting
Led By Pier Paolo Peruzzi, MD, PhD
Research Sponsored by Oliver Jonas, PhD
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 1 day
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the safety and feasibility of using a microdevice to measure local response to chemotherapy and other drugs in brain tumors.
Who is the study for?
Adults with operable brain tumors (WHO grade II-IV gliomas) who can have a microdevice implanted. They must not have had recent chemotherapy or radiotherapy, be on certain enzyme inhibitors, and women must test negative for pregnancy and agree to contraception. Excluded are those with allergies to similar compounds, uncontrolled illnesses, small tumors (<5 cm3), deep brain tumor location, or risks preventing safe anticoagulation cessation.
What is being tested?
The trial is testing the safety of an implantable microdevice that measures how well different drugs work inside malignant brain tumors. These drugs are already approved for treating gliomas but will be delivered locally by the device during surgery.
What are the potential side effects?
Potential side effects may include reactions related to surgical implantation such as infection at the site of surgery, bleeding complications due to the procedure itself or interactions with other medications affecting blood clotting.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Microdevice Related Adverse Events as Assessed by CTCAE Volume 5.0
Success Rate of Microdevice Retrieval
Secondary study objectives
Correlate Tissue Genetic Features with Drug Response
Measure Local Intratumor Response to Different Agents
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MicrodeviceExperimental Treatment1 Intervention
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Patients with newly found supratentorial lesions, or patients previously diagnosed with supratentorial gliomas at time of recurrence, whose treatment plan includes partial or total resection surgery as a component of standard-of-care treatment will be included.
- 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 microdoses for intratumor release of the following 8 approved drugs: Temozolomide, Lomustine, Irinotecan, Carboplatin, Lapatinib, Osimertinib, Abenaciclib, and Everolimus. The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.
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Who is running the clinical trial?
Oliver Jonas, PhDLead Sponsor
Oliver JonasLead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
Pier Paolo Peruzzi, MD, PhDPrincipal InvestigatorBrigham and Women's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your tumor is smaller than 5 cubic centimeters.You have recently had chemotherapy or radiotherapy, or you have not fully recovered from side effects of medication taken more than 4 weeks ago.You have had allergic reactions to similar chemicals or biological substances as the microdevice or any medications used in the study.You are not taking any medications that can affect the way your body processes other drugs.You are able to perform daily activities and take care of yourself with little help.Your organs and bone marrow are working normally based on certain standards.You have an ongoing illness, such as a serious infection or heart problems, or mental health issues that would make it hard for you to follow the study rules.The tumor is located deep inside the brain.You have health conditions that make it unsafe for you to stop taking blood thinning medication according to specific medical guidelines.You have a brain tumor that can be removed with surgery.You need to have a confirmed grade II-IV glioma at the time of surgery. If you already have a confirmed diagnosis from a previous surgery or biopsy, this criterion doesn't apply to you.
Research Study Groups:
This trial has the following groups:- Group 1: Microdevice
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.
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