Methotrexate & Etoposide

“Methotrexate and Etoposide Infusions Into the Fourth Ventricle in Children With Recurrent Posterior Fossa Brain Tumors”

STUDY AT A GLANCE

 

SUMMARY

The main purpose of this protocol is to establish the safety of infusions of methotrexate and etoposide into the fourth ventricle of the brain or prior surgery location in patients with recurrent malignant posterior fossa brain tumors (small space near the brainstem and cerebellum). These tumors include medulloblastoma, ependymoma, atypical teratoid/rhabdoid tumor or other malignant brain tumor with recurrence or progression involving anywhere in the brain and/or spine. Patients' disease must have originated in the posterior fossa of the brain.

STUDY INFORMATION

What to expect:

  • Once a patient has been confirmed to be eligible for study enrollment, and prior to beginning study treatment, all prior medical history will be reviewed, a physical and neurological exam will be completed, blood will be drawn and a lumbar puncture will be done to confirm that it is safe for the patient to receive study treatment and a MRI scan will be done of the brain and spine to check the patients disease.

  • Prior to beginning study treatment, patients will have surgery to place an Ommaya reservoir (special catheter to deliver the study treatment to the brain).  The study doctor may also remove the tumor at the time of the surgery to place to Ommaya reservoir.

  • One the days the patient receives study treatment a neurological exam will be completed

  • Within a week of finishing study treatment, the patient will complete a neurological exam, a lumbar puncture and a blood draw, and will complete an MRI scan to check the status of the patient’s disease after completing treatment.

  • Patients will receive study treatment for a total of 6 weeks

 

APPROACH

 

Treatment:  

  1. Methotrexate: Patients will receive methotrexate through the Ommaya reservoir 2 days a week for 6 weeks (12 total treatments/infusions) . Each infusion will take about 3 minutes to complete.

  2. Etoposide: Patients will receive etoposide through the Ommaya reservoir 5 days a week during treatment week 1, 3 & 5 (15 total treatments/infusions).  Each infusion will take about 3-4 minutes to complete.

ELIGIBILITY

Inclusion Criteria

  • Patient’s must be 1-21 years of age at the time of recurrence or progression

  • Patients with histologically verified medulloblastoma, ependymoma, or atypical teratoid/rhabdoid tumor or other malignant brain tumor with recurrence or progression involving anywhere in the brain and/or spine. Patients' disease must have originated in the posterior fossa of the brain

  • Must have documented evidence of recurrence on MRI scan of the brain and spine

  • Patent must have Ommaya catheter or agree to have one placed

  • A minimum of 7 days since last chemotherapy or radiation treatment and the first study treatment

  • Life expectancy of at least 12 weeks

  • Current neurological deficits must be stable a minimum of 1 week prior to study enrollment

  • Patients must have fully recovered from side effects of prior therapy including chemotherapy, immunotherapy and radiation therapy

  • Patients must have adequate organ function that will be confirmed through a routine blood draw

 

Exclusion Criteria

  • Chemotherapy or radiation therapy within 7 days prior to beginning study treatment

  • Currently enrolled on another treatment trial

  • Current uncontrolled infection

  • Pregnant or lactating women

ADDITIONAL INFORMATION

Full Details on ClinicalTrials.Gov

This protocol is only available at the University of Texas Health Sciences Center (Children’s Memorial Hermann Hospital)

 

CONTACT INFORMATION

Principal Investigator:

David Sandberg, MD

Phone: (713) 500-7410

Email: david.i.sandberg@yth.tmc.edu

Site Coordinator: Bangning Yu, RN, PhD

Phone: 713-500-7363

Email: bangning.yu@uth.tmc.edu

Hope4ATRT Foundation

is a research entity of

Out of Zion, Inc.

Mailing Address: 

P.O. Box 6130   New York, NY  10150