Microdevice for Brain Cancer

Overseen By Pier Paolo Peruzzi, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Oliver Jonas, PhD

Must not be taking: Investigational agents

Disqualifiers: Recent chemotherapy, Radiotherapy, Allergies, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a small implantable device, called a Microdevice, to evaluate its safety and practicality in measuring brain tumors' reactions to certain chemotherapy drugs. The focus is on gliomas, a type of brain tumor, and the device will release tiny doses of drugs already used to treat these tumors. Suitable candidates include those with a newly diagnosed or recurring brain tumor requiring surgery in the upper part of the brain. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking advancements in brain tumor treatment.

Do I need to stop taking my current medications for the trial?

No, you don't need to stop taking your current medications. The trial allows participants to continue their usual medications, even if they affect certain liver enzymes.

What prior data suggests that this microdevice is safe for use in brain cancer treatment?

Research has shown that the implantable microdevice used in brain cancer studies appears safe. In earlier tests, patients experienced no negative effects from the device itself, meaning it caused no harm or unexpected issues. The microdevice has effectively collected important information from tumors, aiding doctors in tailoring treatments for patients.

The drugs used in this study have already received approval for treating brain tumors, so their safety is well-established, and most people tolerate them well. Since this study is in an early stage, it primarily focuses on assessing the safety and practicality of the microdevice for use in humans. This indicates that the researchers are being careful and thorough in evaluating any risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the microdevice treatment for brain cancer because it introduces a novel way to deliver medication directly into the tumor tissue. Unlike the standard of care, which typically involves systemic chemotherapy that affects the whole body, the microdevice allows for precise, local release of microdoses of eight different approved drugs, including Temozolomide and Carboplatin. This direct delivery method can potentially reduce side effects and improve the effectiveness of the drugs by ensuring they reach the tumor more efficiently. Additionally, the microdevice works within a short time frame of just 2-4 hours, offering a rapid assessment of the treatment's impact on the tumor.

What evidence suggests that this microdevice is effective for brain cancer?

Research has shown that tiny devices implanted in the brain can help researchers understand how drugs affect brain tumors like gliomas. In this trial, participants will have microdevices placed in their tumors during surgery. These devices release small amounts of drugs directly into the tumor. Early results suggest they can accurately measure the tumor's reaction to each drug. While these devices seem to work well with regular brain surgeries, researchers are still studying whether they can significantly improve survival rates or slow tumor growth. The drugs used with this device, such as Temozolomide and Lomustine, already treat gliomas, but the device aims to deliver them more effectively. ^{1 2 3 6 7}

Who Is on the Research Team?

Pier Paolo Peruzzi, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants must be evaluated by a neurosurgeon for feasibility of microdevice implantation

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.

Exclusion Criteria

Your tumor is smaller than 5 cubic centimeters.

Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical procedures

Participants who are receiving any other investigational agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Placement of 1-3 microdevices in the tumor tissue before resection, with microdevices dwelling for 2-4 hours to release microdoses of 8 approved drugs

1 day

1 visit (in-person, during surgery)

Follow-up

Participants are monitored for safety and effectiveness after microdevice retrieval and drug response evaluation

up to 30 days

What Are the Treatments Tested in This Trial?

Interventions

• Microdevice

Trial Overview 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.

How Is the Trial Designed?

Group I: Microdevice Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Oliver Jonas, PhD

Lead Sponsor

Trials

1

Recruited

10+

Oliver Jonas

Lead Sponsor

Trials

3

Recruited

40+

Citations

1. cell.com cell.com/device/fulltext/S2666-9986(23)00092-3

Implantable microdevices for treating brain tumors: Device The primary limitation observed across all devices was their modest efficacy in prolonging survival and tumor progression. While most devices ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10754230/

Intratumoral drug-releasing microdevices allow in situ high ... The purpose of this study was explorative, to investigate the safety and feasibility of integrating IMD use during otherwise standard brain surgery for tumor ...

3. ecancer.org ecancer.org/en/news/23666-microdevices-implanted-into-tumours-offer-new-way-to-treat-brain-cancer

Microdevices implanted into tumours offer new way to treat ... The device, which is designed to be used during standard-of-care surgery, provides unprecedented insight into the effects of drugs on glioma ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11250787/

Minimally-invasive implantable device enhances brain cancer ... This study introduces a novel minimally invasive brain tumor suppression (MIBTS) device, combining ultrasound-powered electric field therapy ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04135807?cond=Anaplastic%20oligodendroglioma%20OR%20%22malignant%20oligodendroglioma%22%20OR%20%22%20oligodendroglioma,%20anaplastic,%20malignant%22%20OR%20%22%20oligodendroglioma,%20malignant%22%20OR%20%22%20undifferentiated%20oligodendroglioma%22%20OR%20%22%20WHO%20grade%20III%20oligodendroglial%20neoplasm%22%20OR%20%22%20WHO%20grade%20III%20oligodendroglial%20tumor%22%20OR%20%22%20WHO%20grade%20III%20oligodendroglial%20tumour%22&aggFilters=status:not%20rec&viewType=Table&rank=6

Implantable Microdevice In Primary Brain Tumors This pilot study will assess the safety and feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4825177/

An implantable microdevice to perform high-throughput in ... We have developed an implantable device that can perform drug sensitivity testing of several anticancer agents simultaneously inside the living tumor.

7. news.harvard.edu news.harvard.edu/gazette/story/2023/09/microdevices-implanted-into-tumors-offer-new-way-to-treat-brain-cancer/

Microdevices turn brain tumors into tiny labs None of the patients experienced any adverse effects from the device, and the researchers were able to collect valuable biological data from the ...