Status and phase
Conditions
Treatments
About
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.
Full 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 12 people.
Enrollment
Sex
Ages
Volunteers
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:
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
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
Loading...
Central trial contact
Pier Paolo Peruzzi, MD, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal