Recruiting
Early Phase 1

Microdevice

Sponsor:

Oliver Jonas

Code:

NCT04135807

Conditions

Grade II Glioma

Grade III Glioma

Grade IV Glioma

Astrocytoma

Oligodendroglioma of Brain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Microdevice

Study Details

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.

Conditions

Grade II Glioma

Grade III Glioma

Grade IV Glioma

Astrocytoma

Oligodendroglioma of Brain

Study ID

NCT04135807

Start date

Mar 3, 2020

Status verified date

Oct, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jan 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • 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.

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 cm3.
  • 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Microdevice

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.

Interventions

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.

Primary outcome measure

  • Success Rate of Microdevice Retrieval [ Time Frame: 3 days ]
  • Number of Participants with Microdevice Related Adverse Events as Assessed by CTCAE Volume 5.0 [ Time Frame: 3 Days ]

Central Contacts and Locations

Central contacts

Pier Paolo Peruzzi, MD, PhD

617-732-6600PPERUZZI@PARTNERS.ORG

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Pier Paolo Peruzzi, MD, PhD

617-732-6600PPERUZZI@PARTNERS.ORG

Principal Investigator:

Pier Paolo Peruzzi, MD, PhD

More Information

Sponsor

Oliver Jonas

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Keywords

  • Grade II Glioma
  • Grade III Glioma
  • Grade IV Glioma
  • Astrocytoma
  • Oligodendroglioma of Brain
  • Anaplastic Astrocytoma of Brain
  • Glioblastoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Oliver Jonas on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.