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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Study of Intraventricular Methotrexate With Systemic Topotecan and Cyclophosphamide in Children With Recurrent or Progressive Malignant Brain Tumors

Brief 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.

Detailed 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. This study will attempt to determine via serial MRI scans if methotrexate administration into the lateral or fourth ventricle in combination with systemic intravenous topotecan and cyclophosphamide is effective in reducing tumor burden in the brain and spine for patients with recurrent or progressive brain tumors, including medulloblastoma, ependymoma, PNET (Primitive Neuroectodermal Tumor), atypical teratoid/rhabdoid tumor (AT/RT), and other malignant embryonal tumors. In addition, the study will evaluate the toxicity of the above mentioned experimental treatment during a two-year progression-free survival and survival of children with recurrent malignant brain tumors.
Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Current Primary Outcome: Tumor response [ Time Frame: 6 months ]

MRI response


Original Primary Outcome: Same as current

Current Secondary Outcome: Toxicity of chemotherapy regimen (topotecan and cyclophosphamide) [ Time Frame: 6 months ]

Laboratory results, MRI, physical examination


Original Secondary Outcome: Same as current

Information By: Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Dates:
Date Received: February 11, 2016
Date Started: February 2016
Date Completion: February 2020
Last Updated: January 12, 2017
Last Verified: January 2017