A Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Primary Brain Tumors

Who is this study for? Patients with primary brain tumors
What treatments are being studied? Microdevice
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Pier Paolo Peruzzi, MD, PhD
PPERUZZI@PARTNERS.ORG
617-732-6600
Time Frame
Start Date: 2020-03-03
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 12
Treatments
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.
Sponsors
Leads: Oliver Jonas

This content was sourced from clinicaltrials.gov