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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-12-09

Brief Summary

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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.

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Detailed Description

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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

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intra thecal methotrexate

IT methotrexate via Ommaya reservoir with concomitant systemic topotecan and cyclophosphamide

Group Type EXPERIMENTAL

Intra thecal methotrexate

Intervention Type DRUG

IT methotrexate via Ommaya reservoir with concomitant systemic topotecan and cyclophosphamide

topotecan

Intervention Type DRUG

To be administered in conjunction with methotrexate

cyclophosphamide

Intervention Type DRUG

To be administered in conjunction with methotrexate and topotecan

Interventions

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Intra thecal methotrexate

IT methotrexate via Ommaya reservoir with concomitant systemic topotecan and cyclophosphamide

Intervention Type DRUG

topotecan

To be administered in conjunction with methotrexate

Intervention Type DRUG

cyclophosphamide

To be administered in conjunction with methotrexate and topotecan

Intervention Type DRUG

Other Intervention Names

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Intra thecal methotrexate, topotecan and cyclophosphamide Intra thecal methotrexate, topotecan and cyclophosphamide Intra thecal methotrexate, topotecan and cyclophosphamide

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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.

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No