NCT02684071

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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 description

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.

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

Type	Name	Description
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

Timeline

• Start date: 2016-02-01
• Primary completion: 2019-12-09
• Completion: 2019-12-09
• First posted: 2016-02-17
• Last updated: 2020-01-10

Locations

1 site across 1 country: United States