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:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT05789394
Eligibility Criteria:
Inclusion Criteria:
* Participants \>= 18 years
* Karnofsky Performance Scale (KPS) \>= 60
* Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
* Patients with a previous histological diagnosis of glioblastoma multiforme, isocitrate dehydrogenase (IDH) wildtype (WT) or astrocytoma, IDH-mutant World Health Organization (WHO) grade IV according to the 2021 WHO classification of tumors of the central nervous system , who are candidates to- and will undergo a redo craniotomy for excision of recurrent tumor
* There is measurable disease according to the immunotherapy response assessment in neuro-oncology (iRANO) criteria
* Serum creatinine and urea \<= 2 times the upper limit of normal (=\< 3 weeks prior to registration)
* Alanine transaminase (ALT), aspartate transferase (AST) and alkaline phosphatase =\< 3 times the upper limit of normal, and bilirubin =\< 2.5 mg/dL (=\< 3 weeks prior to registration)
* Prothrombin time =\< 1.5 times upper limit of normal (=\< 3 weeks prior to registration)
* International normalized ratio (INR) and partial thromboplastin time (PTT) =\< 1.5 times the upper limit of normal (=\< 3 weeks prior to registration)
* Hemoglobin \>= 9 g/dL (=\< 3 weeks prior to registration)
* Platelets \>= 100 x 10\^9/L (=\< 3 weeks prior to registration)
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (=\< 3 weeks prior to registration)
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Patient or legally authorized representative (LAR) is able to fully understand and provide written and verbal consent for the protocol
* Willingness to provide mandatory blood specimens for correlative research
* Willingness to provide mandatory tissue specimens for correlative research
* Willingness to undergo Ommaya reservoir placement and provide cerebrospinal fluid (CSF) samples for correlative research
Exclusion Criteria:
* Patients who are undergoing needle biopsy only or non-eligible for a surgical intervention
* Tumors located solely in the brain stem, midbrain, or thalamus without inclusion/involvement of surrounding brain matter
* Previous treatment with bevacizumab
* Radiographic evidence of leptomeningeal disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05789394
Study Brief:
Protocol Section:
NCT05789394