Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466798
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-13
Brief Title:
Fourth Ventricular Administration of Immune Checkpoint Inhibitor Nivolumab and Methotrexate or 5-Azacytidine for Recurrent Medulloblastoma Ependymoma and Other CNS Malignancies
Sponsor:
David Ilan Sandberg
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Fourth Ventricular Administration of Immune Checkpoint Inhibitor Nivolumab and Methotrexate or 5-Azacytidine for Recurrent Medulloblastoma Ependymoma and Other CNS Malignancies
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to assess the safety toxicity and antitumor activity of fourth ventricular infusions of nivolumab plus 5-azacytidine for recurrent ependymoma and nivolumab plus methotrexate for recurrent medulloblastoma and other CNS malignancies
Additionally the study will explore immunologic responses to nivolumab
The hypothesis is that local administration of nivolumab an immune checkpoint inhibitor is safe and will lead to even more robust treatment responses when administered following 5-azacytidine in patients with recurrent ependymoma or methotrexate in patients with medulloblastoma or other CNS tumors
Additionally the study will explore immunologic responses to nivolumab
The hypothesis is that local administration of nivolumab an immune checkpoint inhibitor is safe and will lead to even more robust treatment responses when administered following 5-azacytidine in patients with recurrent ependymoma or methotrexate in patients with medulloblastoma or other CNS tumors
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None