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RecruitingGrade II GliomaGrade III GliomaGrade IV Glioma

Implantable Microdevice In Primary Brain Tumors

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Oliver Jonas

You may qualify if…

  • ✓ 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

You may not qualify if…

  • ✕ 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.

Where it's recruiting

Massachusetts

Boston

Source: ClinicalTrials.gov · NCT04135807 · last updated 2025-07-23

Implantable Microdevice In Primary Brain Tumors · TrialPath