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A Phase II Study of Intraventricular Methotrexate With Systemic Topotecan and Cyclophosphamide in Children With Recurrent or Progressive Malignant Brain Tumors
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.
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.
Age
0 - 22 years
Sex
ALL
Healthy Volunteers
No
Nicklaus Children's Hospital
Miami, Florida, United States
Start Date
February 1, 2016
Primary Completion Date
December 9, 2019
Completion Date
December 9, 2019
Last Updated
January 10, 2020
3
ACTUAL participants
Intra thecal methotrexate
DRUG
topotecan
DRUG
cyclophosphamide
DRUG
Lead Sponsor
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
NCT02271711
NCT02194452
Data Source & Attribution
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