Grade II GliomaEarly Phase 1NCT04135807
Implantable Microdevice In Primary Brain Tumors
A Early Phase 1 study testing Microdevice in people with Grade II Glioma and Grade III Glioma, run by Oliver Jonas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade II Glioma, Grade III Glioma, Grade IV Glioma
- What is being tested?
- Microdevice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2020to 1 Jun 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
- Creatinine within normal institutional limits OR
- Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- Participants must be evaluated by a neurosurgeon who will determine the feasibility of microdevice implantation based on clinical history, extent, and anatomical location of the tumor.
- Because participants will be exposed to microdoses of therapeutic agents only in a localized setting and for a short period of time (2-4 hours), the risk of interaction with other drugs routinely assumed by participants is considered not applicable. Thus, participants receiving any medications or substances that are inhibitors or inducers of CYP450 enzymes remain eligible.
- The effects of the microdevice on the developing human fetus are unknown. For this reason and because the therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential must agree to have a negative serum pregnancy test within 48 hours prior to registration. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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 cm3.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Pier Paolo Peruzzi, MD, PhD, 617-732-6600, PPERUZZI@PARTNERS.ORG
Pier Paolo Peruzzi, MD, PhD
About this study
Official title: A Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With 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 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.
Read the 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 30 people.
- Conditions
- Grade II Glioma, Grade III Glioma, Grade IV Glioma, Astrocytoma, Oligodendroglioma of Brain, Anaplastic Astrocytoma of Brain
- Being tested
- Microdevice
- Keywords
- Grade II Glioma, Grade III Glioma, Grade IV Glioma, Astrocytoma, Oligodendroglioma of Brain, Anaplastic Astrocytoma of Brain, Glioblastoma
- Medical subject headings
- Astrocytoma, Oligodendroglioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrodeviceCombination product
Also called Implantable Microdevice
Placement of 1-3 microdevices (depending on the size of the tumor) approximately 3 days before tumor resection.
The microdevices will dwell in the tumor tissue for a time window of approximately 3 days to allow time for the drug microdoses contained in the devices to diffuse into the tumor, and to allow time for tissue effects of the drugs to be measured. Drugs include: Temozolomide, Lomustine, Irinotecan, Carboplatin, Lapatinib, Niraparib, Osimertinib, Abemaciclib, and Everolimus, Nivolumab, Opdualag, Ipilimumab, Gabapentin, Perampanel, Tocilizumab, Meclofenamate, Bumetanide, Prochloperazine, Decitabine, PTC596, RNA-containing lipid nanoparticle (including compounds CL3, SCR and CL3_a2), and Vortioxetine are released by the microdevice reservoirs. The drugs used in this study will include drugs already used systemically for the treatment of gliomas and investigational agents.
| Study group | Role | What they receive |
|---|---|---|
| Microdevice | Experimental | 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) ~3 days before planned tumor resection. The drugs used in this study will include drugs used systemically for the treatment of gliomas, as well as investigational agents being studied for gliomas: TMZ, Lomustine, Irinotecan, Carboplatin, Lapatinib, Niraparib, Osimertinib, Abemaciclib, and Everolimus, Nivolumab, Opdualag, Ipilimumab, Gabapentin, Perampanel, Tocilizumab, Meclofenam, Bumetanide, Prochloperazine, Decitabine, PTC596, RNA-containing lipid nanoparticle (including compounds CL3, SCR, CL3_a2), Vortioxetine. Receives: Combination Product: Microdevice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success 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.
Measured: 3 days
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:
Measured: 3 Days
Secondary outcomes (2)
Measure Local Intratumor Response to Different Agents
two-tailed alpha level of 0.05 and report 95% confidence intervals with any point estimates
Measured: 3 Days
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.
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start3 Mar 2020
- Primary completion21 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade II GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oliver Jonas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oliver Jonas, Brigham and Women's Hospital
- Investigators
- Pier Paolo Peruzzi, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135807
- Sponsor's protocol ID
- 18-623
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2019
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Primary Brain Tumors
- ClinicalTrials.gov ID
- NCT04135807
- Acronym / sponsor ID
- 18-623
- Conditions
- Grade II Glioma, Grade III Glioma, Grade IV Glioma, Astrocytoma, Oligodendroglioma of Brain, Anaplastic Astrocytoma of Brain
- Keywords
- Grade II Glioma, Grade III Glioma, Grade IV Glioma, Astrocytoma, Oligodendroglioma of Brain, Anaplastic Astrocytoma of Brain, Glioblastoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oliver JonasUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 21 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 30 people.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microdevice | Experimental | Combination Product: MicrodeviceThe 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) ~3 days before planned tumor resection. The drugs used in this study will include drugs used systemically for the treatment of gliomas, as well as investigational agents being studied for gliomas: TMZ, Lomustine, Irinotecan, Carboplatin, Lapatinib, Niraparib, Osimertinib, Abemaciclib, and Everolimus, Nivolumab, Opdualag, Ipilimumab, Gabapentin, Perampanel, Tocilizumab, Meclofenam, Bumetanide, Prochloperazine, Decitabine, PTC596, RNA-containing lipid nanoparticle (including compounds CL3, SCR, CL3_a2), Vortioxetine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrodeviceAlso: Implantable MicrodevicePlacement of 1-3 microdevices (depending on the size of the tumor) approximately 3 days before tumor resection. The microdevices will dwell in the tumor tissue for a time window of approximately 3 days to allow time for the drug microdoses contained in the devices to diffuse into the tumor, and to allow time for tissue effects of the drugs to be measured. Drugs include: Temozolomide, Lomustine, Irinotecan, Carboplatin, Lapatinib, Niraparib, Osimertinib, Abemaciclib, and Everolimus, Nivolumab, Opdualag, Ipilimumab, Gabapentin, Perampanel, Tocilizumab, Meclofenamate, Bumetanide, Prochloperazine, Decitabine, PTC596, RNA-containing lipid nanoparticle (including compounds CL3, SCR and CL3_a2), and Vortioxetine are released by the microdevice reservoirs. The drugs used in this study will include drugs already used systemically for the treatment of gliomas and investigational agents. | Combination product | Microdevice |
Primary outcome
Success Rate of Microdevice Retrieval
Time frame: 3 days
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.
Number of Participants with Microdevice Related Adverse Events as Assessed by CTCAE Volume 5.0
Time frame: 3 Days
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:
2 secondary outcomes
Measure Local Intratumor Response to Different Agents
Time frame: 3 Days
Correlate Tissue Genetic Features with Drug Response
Time frame: 3 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Grade II Glioma
Active, not recruitingPhase 1
Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma
Recurrent Glioblastoma, Recurrent Malignant Glioma
Active, not recruitingPhase 2
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
WHO Grade II Glioma
RecruitingPhase 1
Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)
Recurrent World Health Organization (WHO) Grade II Glioma, Low-grade Glioma
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
Recruiting
Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors
Glioblastoma, WHO Grade II Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pier Paolo Peruzzi, MD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Microdevice in people with Grade II Glioma and Grade III Glioma, run by Oliver Jonas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pier Paolo Peruzzi, MD, PhD (617-732-6600, PPERUZZI@PARTNERS.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate of Microdevice Retrieval (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.