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

Stopped early · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT02684071

Run by

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

People needed

3

Starts

2016-02-01

Expected to finish

2019-12-09

Last updated by the study team

2020-01-10

Who can join

Age: any, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recurrent or progressive supratentorial or posterior fossa tumors with measurable disease on imaging studies of the brain and spine or CSF cytology.
• Tumor histology, including: Medulloblastoma , PNET, or other embryonal tumor, Atypical teratoid/rhaboid tumor (AT/RT), and Ependymoma.
• Leptomeningeal dissemination of a previously diagnosed CNS tumor.
• Diagnosis of tumor pathology will be based upon pathology diagnosis from previous surgeries for patients with recurrent tumors.
• Patients must have received prior radiation before current recurrence, unless the patient is less than 36 months old at diagnosis and has progressed after at least one upfront chemotherapy regimen in which case no prior radiation is required.
• Patients must have a life expectancy of at least 12 weeks as indicated by the patient's oncologist and/or neurosurgeon.
• Lansky or Karnofsky Performance status of at least 50.
• Negative pregnancy test.
• Specific organ function requirements for: Central Nervous System, Bone Marrow, renal and liver.

You may not qualify if…

• Patients that do not meet the inclusion criteria above.
• Pregnant or lactating female patients.
• Patients currently enrolled in another experimental treatment protocol.
• Patients with documented allergies to any of the chemotherapy agents used in this study.
• Patient/Parent refuses study participation.
• Patient is severely somnolent or comatose.
• Unable or unwilling to commit to return or to follow-up visits.

Where it is running

• Nicklaus Children's Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

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