MedTrace Logo

Fourth Ventricular Administration of Immune Checkpoint Inhibitor (Nivolumab) and Methotrexate or 5-Azacytidine for Recurrent Medulloblastoma, Ependymoma, and Other CNS Malignancies

NCT06466798 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

  • Recurrent Ependymoma
  • Recurrent Medulloblastoma
  • CNS Malignancies

Interventions

DRUG

Nivolumab

Nivolumab infusions will be given intraventricularly once every other week for 12 weeks. Dosing will be based upon patient body weight.

DRUG

Methotrexate

2 mg methotrexate infusions will be given intraventricularly daily for 4 consecutive days per week every other week for 12 weeks.

DRUG

5-Azacytidine

10 mg 5-Azacytidine infusions will be given intraventricularly once weekly for twelve consecutive weeks.

Sponsors & Collaborators

  • Jeffrey Treiber

    lead OTHER

Principal Investigators

  • Jeffrey M. Treiber, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2027-07-01
Completion
2027-07-01
FDA Drug
Yes

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06466798 on ClinicalTrials.gov