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Phase II Study of Intraventricular Methotrexate in Children With Recurrent or Progressive Malignant Brain Tumors

NCT02684071 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-01-10

No results posted yet for this study

Summary

The purpose of this research study is to test an experimental treatment method for recurrent or progressive brain tumors in children aged from 0-22 years. The use of methotrexate and chemotherapy (topotecan and cyclophosphamide) is experimental in this study. This means that their use by themselves or together has not been approved by the U.S. Food and Drug Administration for this usage.

Conditions

  • Recurrent Childhood Medulloblastoma
  • Recurrent Childhood Ependymoma
  • Childhood Atypical Teratoid/Rhabdoid Tumor
  • Embryonal Tumor With Abundant Neuropil and True Rosettes
  • Metastatic Malignant Neoplasm to the Leptomeninges

Interventions

DRUG

Intra thecal methotrexate

IT methotrexate via Ommaya reservoir with concomitant systemic topotecan and cyclophosphamide

DRUG

topotecan

To be administered in conjunction with methotrexate

DRUG

cyclophosphamide

To be administered in conjunction with methotrexate and topotecan

Sponsors & Collaborators

  • Nicklaus Children's Hospital f/k/a Miami Children's Hospital

    lead OTHER

Principal Investigators

  • Ziad Khatib, MD · Nicklaus Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-12-09
Completion
2019-12-09

Countries

  • United States

Study Locations

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 NCT02684071 on ClinicalTrials.gov