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|NCT01737671 : Methotrexate Infusion Into the Fourth Ventricle in Children With Malignant Fourth Ventricular Brain Tumors: A Pilot Study|
|Ages||Min: N/A Max: 22 Years|
1. Patients under the age of 22 years with recurrent medulloblastoma (PNET) involving
the brain and/or spine, or recurrent ependymoma involving the brain and/or spine, or
recurrent atypical teratoid/rhabdoid tumor (AT/RT) involving the brain and/or spine.
2. Patients must have a life expectancy of at least 12 weeks as estimated by the
treating oncologist and/or neurosurgeon to be considered for enrollment.
3. Patients must have a Lansky score of 20 or greater = 16 years of age and a
Karnofsky score of 20 or greater > 16 years of age to be eligible for enrollment.
4. Female patients who are post-menarchal must have a negative pregnancy test to be
5. Patients may be enrolled in the study if they have an altered neurological status,
such as somnolence, which is attributed to hydrocephalus and/or mass effect from the
brain tumor by the treating physicians. However, after tumor resection and placement
of the catheter into the fourth ventricle, the protocol will only be continued if the
patient has adequate central nervous system function, defined as: Patient is not
severely somnolent or comatose
6. Prior to receiving intraventricular methotrexate, patients must have adequate bone
marrow function, defined as: Peripheral absolute neutrophil count (ANC) >/= 1000/µL,
Platelet count = 30,000/µL (transfusion independent), Hemoglobin = 9.0 gm/dL (may
receive RBC transfusions)
7. All patients and/or their parents or legal guardians must sign a written informed
1. Patients will be excluded from this study if currently enrolled in another
experimental treatment protocol or if receiving any other chemotherapy (either
systemic or intrathecal).
2. Pregnant or lactating female patients are ineligible
3. Patients will be excluded from this study if they have received another
investigational or chemotherapy agent within 14 days prior to study entry.
4. Patients will be excluded from this study if they have any evidence of infection in
any site at the time of considered enrollment.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01737671
| Link to official Clinicaltrials.gov listing