Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT02279992
Eligibility Criteria:
Inclusion Criteria:
* Patients with recurrent malignant glioma or metastatic brain cancer requiring craniotomy for gross total resection, subtotal resection or biopsy
* Previously histopathologically proven glioma or radiographic appearance of metastatic lesion with a primary neoplasm that is known to metastasize to the brain
* Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
* Patients must have normal hematologic, renal and liver function (i.e. Hemoglobin \>10 gm/dl, Absolute neutrophil count ≥ 1500/mm3, Platelets ≥ 100,000/mm3, creatinine ≤ 1.5 mg/dl or Cr Clearance ≥ 60 mL/min, total bilirubin ≤ 1.5 mg/dl, transaminases ≤ 4 times above the upper limits of the institutional normal.
* Patients must be able to provide written informed consent
Exclusion Criteria:
* Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety
* Patients who are pregnant or breast-feeding
* Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents)
* Allergy to 5HT-(3) receptor antagonist including tropisetron, ondansetron
* Patients on enzyme-inducing anticonvulsants (Dilantin, Tegretol, Phenobarbital)
* Patients with unstable angina or serious cardiovascular disease
* Known HIV positivity or AIDS-related illness
* History of allergic reaction to platinum compounds or mannitol
* Medical conditions requiring the use of oral nitrates
* Patients on alpha-1 adrenergic blockers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02279992
Study Brief:
Protocol Section:
NCT02279992