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Trial record 1 of 1 for:    02940483
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Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Children With Recurrent Posterior Fossa Ependymoma (5-AZA)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by David Ilan Sandberg, The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
David Ilan Sandberg, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT02940483
First received: October 18, 2016
Last updated: August 17, 2017
Last verified: August 2017
  Purpose
The goal of this clinical research study is to establish the safety of direct administration of 5-Azacytidine into the fourth ventricle of the brain or resection cavity in patients with recurrent posterior fossa ependymoma.

Condition Intervention Phase
Brain Tumor Recurrent Drug: 5-Azacytidine Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle or Resection Cavity in Children With Recurrent Posterior Fossa Ependymoma: A Pilot Study

Resource links provided by NLM:


Further study details as provided by David Ilan Sandberg, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Number of patients with grade 3 through grade 5 new neurological adverse events that are related to study drug, graded according to NCI CTCAE Version 4.0 [ Time Frame: 4 months ]
    New neurological deficit defined as new cranial neuropathy, nystagmus, change in mental status, motor deficit or cerebellar finding (ataxia, dysmetria, dysdiadochokinesis) that is attributed by treating physicians to intraventricular 5-Azacytidine infusions. Primary endpoint for basis of safety monitoring is acute toxicity occurring at any time within 30 days of receiving the intraventricular 5-Azacytidine infusion. Rate of acute toxicity monitored using Bayesian method of Thall and Sung. Method of Kaplan and Meier used to estimate unadjusted distributions o time to a neurological deficit and progression free survival time and summary statistic of all variable computed and tabulated.


Estimated Enrollment: 10
Study Start Date: December 2016
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5-Azacytidine Infusion
12 infusions (once a week) into implanted fourth ventricle catheter/Ommaya reservoir following surgical catheter placement into fourth ventricle.
Drug: 5-Azacytidine
5-Azacytidine 10 mg into the fourth ventricle of the brain via the Ommaya reservoir 1 day a week for 12 weeks.
Other Name: Vidaza, Mylosar

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis: Patients with histologically verified ependymoma, with recurrence or progression involving anywhere in the brain and/or spine. To be eligible, patients' disease must have originated in the posterior fossa of the brain.
  • Patient must have either measurable or evaluable tumor as assessed by MRI of the brain and total spine.
  • An implanted catheter in the fourth ventricle or posterior fossa tumor cavity attached to a ventricular access device or agreement to have one placed.
  • A minimum of 7 days between last dose of systemic chemotherapy and/or radiation therapy and first infusion of 5-Azacytidine into fourth ventricle.
  • Life expectancy of at least 12 weeks in the opinion of the PI
  • Lansky score of 50 or greater if ≤16 years of age or Karnofsky score of 50 or greater if > 16 years of age.
  • Existing neurological deficits must have been stable for a minimum of 1 week prior to study enrollment.
  • Patients must have recovered from the acute toxic effects of all prior anticancer chemotherapy
  • Adequate bone marrow function defined by peripheral absolute neutrophil count (ANC) ≥ 500/µL, platelet count ≥ 50,000/ µL (transfusion independent), and hemoglobin ≥9.0 gm/dL (may receive RBC transfusions)
  • Patient or patient's legal representative, parent(s), or guardian able to provide written informed consent.

Exclusion Criteria:

  • Enrolled in another treatment protocol
  • Has received another investigational or chemotherapy agent or radiation therapy within 7 days prior to 5-Azacytidine infusion into the fourth ventricle.
  • Evidence of untreated infection
  • Pregnant of lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02940483

Contacts
Contact: Bangning L Yu, R.N., PhD 713 500-7363 Bangning.Yu@uth.tmc.edu
Contact: David I Sandberg, M.D. 713 500-7410 David.I.Sandberg@uth.tmc.edu

Locations
United States, Texas
UTHealth & Children's Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: David Sandberg, MD    713-500-7410    David.I.Sandberg@uth.tmc.edu   
Contact: Bangning Yu, R.N., PhD    713-500-7363    Bangning.Yu@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: David I Sandberg, M.D. UTHealth
  More Information

Responsible Party: David Ilan Sandberg, Director of Pediatric Neurosurgery, Professor Pediatric Surgery and Neurosurgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02940483     History of Changes
Other Study ID Numbers: HSC-MS-16-0739
Study First Received: October 18, 2016
Last Updated: August 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by David Ilan Sandberg, The University of Texas Health Science Center, Houston:
Ependymoma

Additional relevant MeSH terms:
Ependymoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 25, 2017