Implantable Microdevice In Primary Brain Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Oliver Jonas
Study ID
NCT04135807
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Microdevice — COMBINATION_PRODUCT
    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 (Temozolomide, Lomustine, Irinotecan, Carboplatin, Lapatinib, Osimertinib, Abenaciclib, and Everolimus) released by the microdevice reservoirs. The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.

Study Details

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.

Key Dates

Start date
Mar 3, 2020
Status verified
Jul 2025
Primary completion
Jan 21, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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) 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.

Primary Outcome Measure

Success Rate of Microdevice Retrieval [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Pier Paolo Peruzzi, MD, PhD
[email protected]
617-732-6600
Pier Paolo Peruzzi, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Brigham and Women's Hospital· Boston, MA

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