Implantable Microdevice In Primary Brain Tumors

Launched by OLIVER JONAS · Oct 21, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring the safety and effectiveness of a small implantable device that measures how well brain tumors respond to chemotherapy and other existing drugs. The study focuses on patients with specific types of brain tumors, including different grades of gliomas, which are a type of cancer that affects the brain. The goal is to see if this device can provide useful information about how the tumor reacts to treatment, helping doctors make better decisions for their patients.

To qualify for the trial, participants need to be 18 years or older and have a type of brain tumor that can be surgically removed. They should also be in relatively good health, as determined by their doctor. It's important for potential participants to know that they will undergo a brief procedure to implant the device and will receive small doses of chemotherapy for a short time. Additionally, women of childbearing age must agree to take precautions to prevent pregnancy during the study due to potential risks. Overall, this trial aims to gather important data that could improve future treatments for patients with brain tumors.

Gender

ALL

Eligibility criteria

• 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.