Ensayos clínicos

Inclusion Criteria:

• Age ≥ 18 years old.
• Clinical and radiographic evidence suggesting CNS malignancy.
• Suspected newly diagnosed, local, or intracranial recurrence of primary brain tumor OR Previously untreated or treated brain metastasis.
• Willing to undergo a neurosurgical resection of CNS lesion at Mayo Clinic Rochester.
• Able to have MRI imaging with gadolinium contrast (e.g., no cardiac pacemaker, defibrillator, renal failure).
• Females of childbearing potential must have a negative pregnancy test done < 14 days prior to registration.
• Provide written informed consent.
• Willing to provide tissue and blood samples for research purposes
• For patients having a study-specific surgical planning MRI only.  The following lab values obtained ≤ 30 days prior to registration:
  • Creatinine (eGFR ≥ 30).

Exclusion Criteria:

• Vulnerable populations: pregnant women, prisoners, mentally handicapped.
• Unable to undergo a biopsy of CNS lesion.
• Documented drug allergy to cefazolin, levetiracetam, or other study drugs, or other contraindication to use these drugs in the pre-operative setting (e.g., patient is already on another anti-seizure medication which precludes the clinical indication for pre-operative levetiracetam).
• Patients who are unable to swallow tablets if study drug is administered by mouth.
• Patients who are at risk for impaired absorption of oral medication if study drug is administered by mouth. Note: This includes but not limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal resection.
• Pregnant or nursing women.
  • Note: Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects with chemotherapy. There is also a potential risk for AEs in nursing infants secondary to treatment of the mother with these drugs, so breastfeeding should be discontinued for the duration of the study.